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Trial registered on ANZCTR


Registration number
ACTRN12623000760673
Ethics application status
Approved
Date submitted
25/04/2023
Date registered
12/07/2023
Date last updated
19/12/2024
Date data sharing statement initially provided
12/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants
Scientific title
A Double-Blinded, Randomized, Placebo-controlled, Single-And Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants
Secondary ID [1] 309485 0
ELVN-001-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukamia 329756 0
Condition category
Condition code
Cancer 326653 326653 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ELVN-001 is a potent, adenosine triphosphate (ATP)-competitive small molecule inhibitor of the cytoplasmic Abelson Tyrosine Kinase (ABL, also known as Abl1 or c-Abl). Constitutional activation of ABL has been implicated in leukemia and neurodegenerative diseases.
Investigational Product: ELVN-001
Dosage Formulation: ELVN-001 will be supplied in two formats: one containing 10 mg ELVN-001 capsules, the other containing 40 mg ELVN-001 capsules
Route of Administration: Oral
The study is composed of 3 parts:
Part A (Single Ascending Dose [SAD]) will be conducted to assess the PK, safety, and tolerability of ELVN-001 in healthy participants following a single dose of ELVN-001 or matching placebo at a ratio of 6:2 in each cohort. Seven cohorts will be included in Part A where a single dose of ELVN-001 will be administered per cohort.
Part B (Multiple Ascending Dose [MAD]) will be conducted to assess the PK, safety, and tolerability of ELVN-001 in healthy participants following a daily dose of ELVN-001 administered over 10 days of the study or matching placebo at a ratio of 6:2 in each cohort
Part c (Food Effect[FE]) will be conducted to assess the food effect on the PK, safety and tolerability of ELVN-001 following a single dose in healthy participants

In Part A, Single Ascending Dose (SAD), Participants will receive a single dose of ELVN-001 or matching placebo on Day 1 after a minimum 10 hour fast.
Cohort 1: Participant will receive 10 mg of ELVN-001 once on Day 1
Cohort 2: Participant will receive 20 mg of ELVN-001 once on Day 1
Cohort 3: Participant will receive 40 mg of ELVN-001 once on Day 1
Cohort 4: Participant will receive 80 mg of ELVN-001 once on Day 1
Cohort 5: Participant will receive 120 mg of ELVN-001 once on Day 1
Cohort 6: Participant will receive 160mg of ELVN-001 once on Day 1
Cohort 7 (optional) : Participant will receive 200mg of ELVN-001 once on Day 1


Treated participants in Part A (SAD) will be confined to the Clinical Research Unit from Day -1 through to Day 6 (inclusive), until all required assessments have been performed and there is no medical reason for a longer stay in the Clinical Research Unit (CRU).
After eligibility determination at both Screening and Day -1, the participants will be admitted to the Clinical Research Unit (CRU) on Day -1 and will start fasting for at least 10 hours before the dosing on Day 1.

Participants in the Part B (MAD) will receive a daily dose of ELVN-001 or matching placebo after a minimum 2 hour fast from Day 1 to Day 10. Participants in Part B will also remain fasted for at least 1 hour post dose. Participants will be confined to the Clinical Research Unit (CRU), from Day -1 to Day 11, until all required assessments have been performed and there is no medical reason for a longer stay in the Clinical Research Unit (CRU), based on the Investigator’s discretion. A study monitor will be identified and will be responsible.
Enrolment into the Part B (MAD [ie, MAD Cohort 1]) may be initiated concomitantly with Part A (SAD) Cohort 2, after the dose regimens in Part A (SAD) Cohort 1 to Cohort 4 have been recommended by the Safety Review Committee (SRC) to be safe and well tolerated. SRC decisions on dose escalation during Part B (MAD) will be based on safety and tolerability data from each cohort.
Participants in Part c (Food Effect)- Target sample size- 88
After SAD Cohort 5(120mg), Participants will be randomly assigned to sequence 1(S1) or sequence 2(S2) with a ratio of 1:1. Participants in S1 will receive a single oral dose of 120mg ELVN-001(with water 240 mL) on Day 1 in fasted conditions and Day 6 in fed conditions and in S2 will receive a single oral dose of 120mg ELVN -001 (with water 240mL) on Day 1 in fed conditions and Day 6 in fasting conditions.
Participants in Part C (FE) will be confined to the CRU from Day -1 through to Day 9 (inclusive), until all required assessments have been performed and there is no medical reason for a longer stay in the CRU, based on the Investigator’s discretion.
For the fed period, Participants will consume a high-fat, high-calorie breakfast, as recommended by the U.S. Food and Drug Administration (FDA 2022), following an overnight fast of at least 10 hours. The high-fat, high calorie meal will follow that if the US FDA guidance (FDA 2022). Approximately 50% of total caloric content of the meal should be from fat and the meal approximately 800 to 1000 calories in total. A typical meal is two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. This meal derives approximately 150, 250, and 500-600 calories from protein, carbohydrates and fat, respectively. ELVN-001 will be administered orally within 30 minutes after the participants begin consuming the meal.
Participants will continue fasting for at least 4 hours after dosing (water intake will be permitted from 1 hour after dosing).
For the fasted period, ELVN-001 will be administered orally following an overnight fast of at least 10 hours. Participants will continue fasting for at least 4 hours after dosing (water intake will be permitted from 1 hour after dosing)
Intervention code [1] 325913 0
Treatment: Drugs
Comparator / control treatment
Placebo Control Study.
Placebo Capsule will be supplied in 2 formats:
1. Lactose monohydrate in size 3 white opaque hydroxypropyl methylcellulose (HPMC) capsules
2. Lactose monohydrate in size 0 Swedish Orange hydroxypropyl methylcellulose (HPMC) capsule
Control group
Placebo

Outcomes
Primary outcome [1] 334518 0
Part A (SAD):
• To determine the PK of ELVN-001 following a single dose

Plasma PK parameters will be calculated following a single dose of ELVN-001 including but not limited to: Maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last), AUC from time 0 to infinity (AUC0-inf), and half-life (t½), apparent oral body clearance (CL/F) and apparent volume of distribution (Vz/F).
Timepoint [1] 334518 0
PK blood samples will be collected on Day 1 (Pre-dose within 1 hour prior to dosing, 0.25 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 (48 hours post-dose), Day 5 (96 hours post-dose) and Day 6 (120 hours post-dose)
Primary outcome [2] 334519 0
Part A (SAD):
To determine the safety and tolerability profile of ELVN-001 following a single dose in healthy participants
Safety Parameters:
• AEs, serious adverse events (SAEs): Severity of AEs are to be graded by the PI, based off the Common Terminology Criteria for Adverse Events (CTCAE [Version 5.0]) criteria
• Clinically significant changes from Baseline in laboratory results: Abnormal laboratory findings (eg, hematology, biochemistry, coagulation and serology)
• Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12-lead ECG readings. Vital signs will be measured by body temperature, systolic and diastolic blood pressure by a sphygmomanometer, heart rate by a Holter monitor, and respiratory rate by a oximeter. Body temperature will be measured using an oral thermometer.
Timepoint [2] 334519 0
AEs and SAEs assessed continuously from baseline to Day 6 post-baseline (end of study)
Clinically significant changes in daily laboratory results from baseline to Day 6 post-baseline (end of study)
Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12-lead ECG readings conducted daily from baseline to Day 6 post-baseline (end of study)
Primary outcome [3] 334520 0
Part B (MAD):
• To determine the PK of ELVN-001 following multiple doses
• Plasma PK parameters will be calculated following multiple doses of ELVN-001, including but not limited to: Maximum plasma concentration at steady state (Cmax,ss), time to Cmax,ss (tmax,ss), AUC from time 0 to 24 (AUC0-24), AUC over the dosing interval (AUC0-tau), accumulation ratios (RA) for Cmax and AUC0-24 and half-life (t1/2).
Timepoint [3] 334520 0
PK blood sampling will be performed on Day 1 (0.25 hours, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post-dose), Day 2 (24 hours/pre-dose and 1 hour post dose) , Day 4, 6, 8, 9 (Pre-dose and 1 hour post-dose), Day 10 (Pre-dose and 0.25 hours, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours post-dose) and 11 (24 hours post-dose)
Secondary outcome [1] 420984 0
To determine the safety and tolerability profile of ELVN-001 following multiple doses in healthy participants
Safety Assessments will be done by:
• AEs, serious adverse events (SAEs) : Severity of AEs are to be graded by the PI, based off the Common Terminology Criteria for Adverse Events (CTCAE [Version 5.0]) criteria
• Clinically significant changes from Baseline in laboratory results: Abnormal laboratory findings (eg, hematology, biochemistry, coagulation and serology)
• Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12-lead ECG readings. Vital signs will be measured by body temperature, systolic and diastolic blood pressure by a sphygmomanometer, heart rate by a Holter monitor, and respiratory rate by a oximeter. Body temperature will be measured using an oral thermometer.
Timepoint [1] 420984 0
AEs and SAEs assessed continuously from baseline to Day 11 post-baseline (end of study)
Clinically significant changes in daily laboratory results from baseline to Day 11 post-baseline (end of study).
Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12-lead ECG readings conducted daily from baseline to Day 11 post-baseline (end of study)
Secondary outcome [2] 420985 0
Blood Concentration-QTc analyses in participants following single and multiple dosing.
Assessments will be done QTc interval changes from Baseline to Day 6 in both ELVN-001 treated and placebo participants and the correlation of QTc with plasma concentrations of ELVN-001 will be assessed in Part A
• QTc interval changes from Baseline in both ELVN-001 treated and placebo participants and the correlation of QTc with plasma concentrations of ELVN-001 will be assessed in Part B through Holter Monitoring.
Timepoint [2] 420985 0
Part A: From baseline to Day 6 post-baseline
Part B: From baseline to Day 11 post-baseline
Secondary outcome [3] 443304 0
To evaluate the effect of food on a subsequent single dose of ELVN-001 in healthy participants. Part C will be implemented following the completion of SAD Cohort 5, i.e. after enrolment of 40 participants



Plasma PK parameters will be calculated following a single dose of ELVN-001 under fasted and fed conditions Cmax, tmax, AUClast, AUC0-inf, as well as clearance (CL/F), terminal half-life (t1/2), apparent terminal elimination rate constant (Kel), and volume distribution Vz/F, where possible. with ratios of AUC and Cmax
Timepoint [3] 443304 0
Secondary outcome [4] 443305 0
To evaluate the effect of food on a subsequent single dose of ELVN-001 in healthy participants. Part C will be implemented following the completion of SAD Cohort 5, i.e. after enrolment of 40 participants



Plasma PK parameters will be calculated following a single dose of ELVN-001 under fasted and fed conditions Cmax, tmax, AUClast, AUC0-inf, as well as clearance (CL/F), terminal half-life (t1/2), apparent terminal elimination rate constant (Kel), and volume distribution Vz/F, where possible. with ratios of AUC and Cmax
Timepoint [4] 443305 0
PK blood sampling will be performed on Day 1 (Predose, 0.25 hours, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post-dose), Day 2 (24 hours, 48 hours, 72 hours post dose) , Day 3 (48hours post dose), Day 4 (72 hours post dose), Day 6 (120 hours Pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours), Day 7 (24 hours), Day 8 (48 hours), Day 9 (72 hours)
Secondary outcome [5] 443306 0
To determine the safety and tolerability profile of ELVN-001 following a single dose in healthy participants under fasted and fed conditions

• AEs, serious adverse events (SAEs): Severity of AEs are to be graded by the PI, based off the Common Terminology Criteria for Adverse Events (CTCAE [Version 5.0]) criteria • Clinically significant changes from Baseline in laboratory results: Abnormal laboratory findings (eg, hematology, biochemistry, coagulation and serology) • Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12- lead ECG readings. Vital signs will be measured by body temperature, systolic and diastolic blood pressure by a sphygmomanometer, heart rate by a Holter monitor, and respiratory rate by an oximeter. Body temperature will be measured using an oral thermometer.
Timepoint [5] 443306 0
PK blood sampling will be performed on Day 1 (Predose, 0.25 hours, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours post-dose), Day 2 (24 hours, 48 hours, 72 hours post dose) , Day 3 (48hours post dose), Day 4 (72 hours post dose), Day 6 (120 hours Pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours), Day 7 (24 hours), Day 8 (48 hours), Day 9 (72 hours)
Secondary outcome [6] 443307 0
To determine the safety and tolerability profile of ELVN-001 following a single dose in healthy participants under fasted and fed conditions

• AEs, serious adverse events (SAEs): Severity of AEs are to be graded by the PI, based off the Common Terminology Criteria for Adverse Events (CTCAE [Version 5.0]) criteria • Clinically significant changes from Baseline in laboratory results: Abnormal laboratory findings (eg, hematology, biochemistry, coagulation and serology) • Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12- lead ECG readings. Vital signs will be measured by body temperature, systolic and diastolic blood pressure by a sphygmomanometer, heart rate by a Holter monitor, and respiratory rate by an oximeter. Body temperature will be measured using an oral thermometer.
Timepoint [6] 443307 0
AEs and SAEs assessed continuously from baseline to Day 9 post-baseline (end of study) Clinically significant changes in daily laboratory results from baseline to Day 9 post-baseline (end of study) Clinically significant change from Baseline in Physical Examinations, Vital Sign Measurements, and 12-lead ECG readings conducted daily from baseline to Day 9 post-baseline (end of study)

Eligibility
Key inclusion criteria
To be eligible for this study, a participant must meet all of the following inclusion criteria:
Age
1. Participants greater than and equal to 18 to lesser than 60 years of age at time of informed consent.

Type of Patient and Disease Characteristics
2. Normal healthy male and female participants with no clinically significant medical history, and no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP at the discretion of the PI or designee

General Inclusion Criteria
3. Able to provide written informed consent to participate in this study.
4. Healthy and free from clinically significant illness or disease with clinical laboratory values at Screening and Day -1 (including haematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not
clinically significant by the PI or designee.
5. Have a body mass index (BMI) between 18.5 and 30 kg/m2 , inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive, at Screening.
6. Able to understand the nature of the study and any risks associated with participation and willing to cooperate and comply protocol restrictions and requirements.
7. Agrees to the meals, dietary and lifestyle restrictions outlined in the protocol during the course of the study.
8. Estimated glomerular filtration rate (eGFR): more than 89 mL per min per 1.73 meter square for participants 18 to 59 years old, or more than 84 mL per min per 1.73 meter square for participants 60 years old) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
9. Systolic blood pressure of 90 to 140 mmHg and diastolic blood pressure of 40 to 90 mmHg.
10. Resting heart rate of 45 to 100 beats per minute (bpm).

Reproductive Status
Male participants:
11. A male participant must agree to use contraception, during the treatment period and for at least 90 days after the last dose of IP and refrain from donating sperm during this period. Male participant whose partners are Women of Child bearing potential (WOCBP) can be eligible if they use condoms during intercourse and their WOCBP partners use one of the following contraceptive measures for at least 90 days following the last dose of IP.
• Hormonal contraception (oral, implant, injectable)
Intrauterine device (IUD) or intrauterine system (IUS)
• Tubal ligation
• Simultaneous use of diaphragm or cervical cap and male condom for the male partner
Female participants:
12. A female participant is eligible to participate if she is not pregnant, not breastfeeding and at least one of the following conditions applies:
• Not a woman of childbearing potential, OR
• Must agree to use contraception, as detailed in the protocol, during the treatment period and for at least 90 days after the last dose of IP.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply. No waivers will be granted.
1. Previous participating a trial with ELVN-001.
2. .Received any prescribed systemic or topical medications, or live vaccination within 30 days (or less than 5 half-lives, whichever is longer) or any inactivated vaccination within 72 hours prior to first dose of the IP
3. Potential participant has used any other IP or investigational medical device within 30 days prior to Screening.
4. Family history (biological relatives [ie, parents, siblings]) of long or short QT syndrome, or Torsades de Pointes.
5. Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval more than 450 ms (male) or more than 470 ms (female) corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]) that are considered by the PI or designee to be clinically significant.
6. Presence or history of drug and or alcohol abuse including a positive result on the urine drug
screen or alcohol breath test at Screening or Day -1.
7. Excessive intake of caffeine-containing drinks or food as judged by the Investigator. Excessive
intake is defined as more than 400 mg of caffein per day (equivalent to 4 or 5 cups of brewed
coffee).
8. Use of tobacco or nicotine-containing products within 3 months prior to first dose of IP and during the course of the study.
9. Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 & HIV 2 antibodies. If a participant tests positive for HCV antibodies, they may still be allowed into the trial if HCV Ribonucleic acid [RNA] is undetectable in a follow-up assessment.
10. Plasma donation within 30 days of Screening or any blood loss or donation more than 500 mL
during the 90 days prior to Screening.
11. History or presence of gastrointestinal (including a previous episode of pancreatitis), hepatic or
renal disease, or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
12. A female participant is pregnant or breastfeeding.
13. Unwillingness to refrain from strenuous exercise 48 hours prior to CRU confinement and for the
duration of the study.
14. History of lactose intolerance.
15. Positive cotinine test at Screening or Day -1.
16. Is at suicidal risk in the opinion of the PI as per the following criteria:
• Any suicidal attempts within 12 months prior to Screening.
• Any suicidal intent including a plan or Columbia-Suicide Severity Rating Scale (C-SSRS) answer of "YES" on suicidal ideation currently or within 3 months.

For Part C (FE) Only:
17. A participant who is unable to consume a high-fat, high calorie breakfast (containing
eggs, butter, bacon, white bread, hash browns, and whole milk).

Prior/Concomitant Therapy
18. Unwillingness to abstain from concomitant therapy for the duration of the study (with the exception of medications used to treat adverse symptoms associated with ELVN-001 administration and permitted contraception). Over the counter (OTC) medication, herbal remedies, supplements, or vitamins are not permitted for 7 days prior to dosing, and during the study without prior approval of the PI and designee.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/06/2023
Date of last participant enrolment
Anticipated
5/12/2023
Actual
26/10/2023
Date of last data collection
Anticipated
15/12/2023
Actual
9/11/2023
Sample size
Target
80
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313681 0
Commercial sector/Industry
Name [1] 313681 0
Enliven Therapeutics, Inc.
Country [1] 313681 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Enliven Therapeutics, Inc.
Address
6200 Lookout Road, Boulder, CO, 80301, US
Country
United States of America
Secondary sponsor category [1] 315482 0
None
Name [1] 315482 0
Address [1] 315482 0
Country [1] 315482 0
Other collaborator category [1] 282637 0
Commercial sector/Industry
Name [1] 282637 0
Novotech (Australia) Pty Limited
Address [1] 282637 0
Level 3, 235 Pyrmont Street Sydney, NSW Australia - 2009
Country [1] 282637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312845 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312845 0
Ethics committee country [1] 312845 0
Australia
Date submitted for ethics approval [1] 312845 0
12/04/2023
Approval date [1] 312845 0
12/05/2023
Ethics approval number [1] 312845 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126122 0
Prof Andrew Redfern
Address 126122 0
Linear Clinical Research, Level 1, B Block Hospital Avenue Nedlands, WA 6009 Australia
Country 126122 0
Australia
Phone 126122 0
+61 414 801 448
Fax 126122 0
Email 126122 0
andrew.Redfern@health.wa.gov.au
Contact person for public queries
Name 126123 0
Qi Wang
Address 126123 0
Enliven Therapeutics, Inc.
6200 Lookout Road, Boulder, CO 80301, US
Country United States of America
Country 126123 0
United States of America
Phone 126123 0
+1 609 651 2686
Fax 126123 0
Email 126123 0
qi.wang@enliventherapeutics.com
Contact person for scientific queries
Name 126124 0
Helen Collins
Address 126124 0
Enliven Therapeutics, Inc. 6200 Lookout Road, Boulder, CO 80301, US Country United States of America
Country 126124 0
United States of America
Phone 126124 0
+1 707 799 3272
Fax 126124 0
Email 126124 0
helen.collins@enliventherapeutics.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.