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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05105243




Registration number
NCT05105243
Ethics application status
Date submitted
29/09/2021
Date registered
3/11/2021

Titles & IDs
Public title
Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766 in Healthy Subjects
Secondary ID [1] 0 0
CVN-766
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety Issues 0 0
Tolerance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CVN766

Active comparator: SAD Cohort 1 - Each dose cohort: 8 participants (6 active:2 placebo). 5 mg.

Active comparator: SAD Cohort 2 - Each dose cohort: 8 participants (6 active:2 placebo). 15 mg.

Active comparator: SAD Cohort 3 - Each dose cohort: 8 participants (6 active:2 placebo). 45 mg.

Active comparator: SAD Cohort 4 - Each dose cohort: 8 participants (6 active:2 placebo). 125 mg.

Placebo comparator: SAD Cohort 5 - Each dose cohort: 8 participants (6 active:2 placebo). 250 mg.

Active comparator: MAD Cohort 1 - Each dose cohort: 8 participants (6 active:2 placebo). 45mg.

Placebo comparator: MAD Cohort 2 - Each dose cohort: 8 participants (6 active:2 placebo). 125 mg.

Placebo comparator: MAD Cohort 3 - Each dose cohort: 8 participants (6 active:2 placebo). 250 mg.


Treatment: Drugs: CVN766
highly selective orexin-1 receptor (Ox1R) antagonist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
Timepoint [1] 0 0
Up to Day 14
Primary outcome [2] 0 0
Percentage of Participants With Clinically Significant Abnormal Laboratory Parameters
Timepoint [2] 0 0
Up to Day 14
Primary outcome [3] 0 0
Percentage of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Timepoint [3] 0 0
Up to Day 14
Primary outcome [4] 0 0
Percentage of Participants With Clinically Significant Abnormal Vital Signs
Timepoint [4] 0 0
Up to Day 14
Secondary outcome [1] 0 0
Time to Maximum Plasma Concentration (Cmax) (Tmax) After Single Dose Administration of CVN766
Timepoint [1] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1
Secondary outcome [2] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to 24 (AUC24) After Single Dose Administration of CVN766
Timepoint [2] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16 and 24 hours postdose at Day 1
Secondary outcome [3] 0 0
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC [0-infinity]) After Single Dose Administration of CVN766
Timepoint [3] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1
Secondary outcome [4] 0 0
Terminal Elimination Half-life (t1/2z) After Single Dose Administration of CVN766
Timepoint [4] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1
Secondary outcome [5] 0 0
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Timepoint [5] 0 0
At Days 1, 2, 3, 4, 5 and 6
Secondary outcome [6] 0 0
Cmax After Repeat Dose Administration of CVN766
Timepoint [6] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, and 24 (Day 2 predose) hours postdose at Day 1
Secondary outcome [7] 0 0
AUC From Time 0 to the End of Dosing Interval (AUCtau) After Repeat Dose Administration of CVN766
Timepoint [7] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [8] 0 0
T1/2z After Repeat Dose Administration of CVN766
Timepoint [8] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [9] 0 0
Accumulation Ratio (Rac) of Cmax After Repeat Dose Administration of CVN766
Timepoint [9] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [10] 0 0
Rac of AUC After Repeat Dose Administration of CVN766
Timepoint [10] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [11] 0 0
Time to Reach Steady State of CVN766 Concentration in the Dosing Interval
Timepoint [11] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [12] 0 0
Steady State Cmax After Repeat Dose Administration of CVN766
Timepoint [12] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [13] 0 0
Steady State Minimum Observed Plasma Concentration (Cmin) After Repeat Dose Administration of CVN766
Timepoint [13] 0 0
Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7
Secondary outcome [14] 0 0
Ratio of the CVN766 Concentration in Cerebrospinal Fluid (CSF) Versus the Plasma Concentration After Single Ascending Dose of CVN766 45 mg
Timepoint [14] 0 0
At 3 hours post-dose
Secondary outcome [15] 0 0
Ratio of the CVN766 Concentration in CSF vs the Plasma Concentration After Repeated Dose Administration of CVN766
Timepoint [15] 0 0
At 3 hours post-dose

Eligibility
Key inclusion criteria
* Participant eligibility is determined according to the following criteria prior to entry into the study:

1. In the investigator's opinion, the participant can understand and sign the Informed Consent Form and comply with all protocol requirements.
2. The participant is a healthy male or female adult who is 18 to 55 years of age, inclusive at the time of ICF.
3. Participant weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 32.0 kg/m2, inclusive at Screening.
4. A male participant who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing the ICF throughout the study and for 12 weeks after the last dose.

*Definitions and acceptable methods of contraception are defined in Section 9.1.9 Contraception and Pregnancy Avoidance Procedure, and reporting responsibilities are defined in Section 9.1.10 Pregnancy.
5. A female participant of childbearing potential who complies with contraception requirements* or a female with no childbearing potential, defined as the participant has been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH>40 IU/L).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any participant who meets any of the following criteria will not qualify for entry into the study:

1. Participant has received any investigational compound within 30 days prior to the first dose of study medication or within 5 half-lives, whichever is greater.
2. Participant is a study site employee or an immediate family member of a study site employee.
3. Participant has evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, full-body allergic skin rash (including hives), psychiatric disorder, or other abnormality that may impact the ability of the participant to participate or potentially confound the study results.
4. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking CVN766 or a similar drug in the same class or that might interfere with the conduct of the study.
5. Participant has a known hypersensitivity to any component of the formulation of CVN766.
6. Participant has a positive urine result for drugs of abuse at Screening or Inpatient Check-in (Day -1).
7. Participant has a history of drug abuse or a history of alcohol abuse (more than 14 units/week) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
8. Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table as listed in Table 3: Excluded Medications and Dietary Products.
9. Male participants who do not agree to all the following rules: when sexually active with a female partner(s) of childbearing potential during the study, and for 12 weeks after the last dose of study drug: a) must use an acceptable method of birth control (condom or surgical sterilization) and b) refrain from sexual activity with female partners who do not use an acceptable method of birth control. Barrier contraception (condom) must be used by all-male participants who were not surgically sterilized at least 90 days prior to screening. Male participants must also agree to refrain from sperm donation during the study and until 12 weeks after the last dose of study drug.
10. Female participants who are pregnant or breastfeeding or plan to become pregnant or donate ova during the study or 30 days after the last dose of the study drug. Women of childbearing potential must agree to practice an acceptable method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence).

*Definitions and acceptable methods of contraception are defined in Section 9.1.9, Contraception and Pregnancy Avoidance Procedure, and reporting responsibilities are defined in Section 9.1.10, Pregnancy.
11. Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.
12. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption [e.g., bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [i.e., more than once per week] occurrence of heartburn).
13. Participant has a history of cancer or other malignancy, except for basal cell carcinoma or squamous cell carcinoma that has been in remission for at least 3 years prior to Day 1.
14. Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or a human immunodeficiency virus infection at Screening.
15. Participant who regularly use nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum). Casual user may participate but must agree to refrain from the time of Screening through the duration of the study or a positive urine cotinine test at Inpatient Check-in (Day 1).
16. Participant has poor peripheral venous access (defined as more than three failed attempts to cannulate).
17. Participant has donated or lost 450 mL or more of their blood volume (including plasmapheresis) or had a transfusion of any blood product within 45 days prior to Day 1.
18. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or medically qualified sub-investigator.
19. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
20. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
21. Participant has a QT interval with Fridericia's correction method (QTcF) >450 ms (males) or >470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit.
22. Participant has abnormal Screening or Inpatient Check-in (Day -1) laboratory values that suggest a CS underlying disease or participant with the following lab abnormalities: ALT and/or AST >1.5 the ULN, confirmed with one repeat testing.
23. Participant has a risk of suicide according to the investigator's clinical judgment or has made a suicide attempt in the previous 2 years.

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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/11/2022
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cerevance
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Ottavio Vitolo, MD
Address 0 0
Cerevance
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05105243