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Trial registered on ANZCTR


Registration number
ACTRN12620000894998
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
10/09/2020
Date last updated
15/09/2021
Date data sharing statement initially provided
10/09/2020
Date results information initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, randomised, double blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and repeat doses of AMP945 administered orally to healthy adult volunteers
Scientific title
A Phase I, randomised, double blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and repeat doses of AMP945 administered orally to healthy adult volunteers
Secondary ID [1] 301844 0
AMP945-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 318327 0
Idiopathic pulmonary fibrosis 318328 0
Condition category
Condition code
Cancer 316342 316342 0 0
Pancreatic
Respiratory 316343 316343 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A, single ascending doses: Oral AMP945 capsules administered once with water to in-patients after an overnight fast of 10 hours. Dosing compliance will be assessed by hand and mouth checks. The starting dose (Cohort 1) will be 15mg, and subsequent doses (Cohorts 2 to 5) will be decided based on safety and pharmacokinetic data. The maximum dose will not exceed 1000mg.

Part B: Oral AMP945 capsules administered once with water to in-patients immediately after a high fat meal (at least 50% fat) following an an overnight fast of 10 hours. Dosing compliance will be assessed by hand and mouth checks. The dose will be decided based on Part A data, and the relevant Part A cohort will return at least 7 days after dosing for Part B.

Part C, multiple ascending doses: Oral AMP945 capsules administered with water to in-patients after an overnight fast of 10 hours, once a day for 7 days. Dosing compliance will be assessed by hand and mouth checks. The starting dose will be decided based on Part A and Part B data, and subsequent doses decided based on safety and pharmacokinetic data
Intervention code [1] 318138 0
Treatment: Drugs
Comparator / control treatment
Part A and Part B: Oral placebo capsules (microcellulose) administered once.
Part C: Oral placebo capsules (microcellulose) administered once a day for 7 days.
Control group
Placebo

Outcomes
Primary outcome [1] 324508 0
Safety and tolerability will be assessed by vital signs, clinical safety labs, electrocardiograms (ECGs), physical exams and adverse events.
Timepoint [1] 324508 0
Part A and Part B: Dosing on Day 1, daily in-patient monitoring for 3 days plus follow up visit on Day 7
Part C: Dosing on Day 1, daily in-patient monitoring for 8 days plus follow up visit on Day 14
Secondary outcome [1] 384839 0
Plasma pharmacokinetics of AMP945, including AUC, Tmax, Cmax, T1/2
Timepoint [1] 384839 0
Part A and Part B: At 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post dose

Part C: At 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post dose, on Day 1 and Day 7, prior to drug administration on Days 3 to 6, and on Day 14.
Secondary outcome [2] 384840 0
Urine pharmacokinetics of AMP945, including absorption and elimination
Timepoint [2] 384840 0
Part A and Part B: Dosing on Day 1, pooled samples 0-4, 4-12, 12-24 hours post dose, and a spot urine sample at 24, 36, and 48 hours post dose, and on Day 7

Part C: Dosing on Day 1, pooled samples samples 0-4, 4-12, 12-24 hours post dose, on Day 1 and Day 14, and spot samples prior to drug administration on Days 2 to 6, and on Day 14.

Eligibility
Key inclusion criteria
• Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- Are aged 18 to 50 years old at the time of consent.
- Are in good general health without clinically significant medical history.
- Weigh at least 50kg and have a body mass index at least 18 and less than 30kg/m2.
- Agree to practice effective contraception during the study period and for 3 months after their last dose of study drug
- Provision of written informed consent
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Are pregnant or breastfeeding.
- Received any investigational medicinal product within 30 days or 5 half-lives, whichever is longer (4 months if the previous drug was a new chemical entity) prior to Baseline (Day 1).
- Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days, or blood products or a registered vaccine within 30 days prior to Day 1.
- Have a history of anaphylactic or severe allergic reactions.
- Have poor venous access.
- Are Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C positive.
- Smoke more than 2 cigarettes (or equivalent) per week.
- Have any abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) values, bilirubin greater than 1.5 upper limit of normal, or clinically significant abnormal findings in laboratory tests, vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator.
- Have a bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Have clinical signs of active infection and/or a temperature of greater than 38.0°C at the time of Screening or Baseline. Study entry may be deferred at the discretion of the Principal Investigator
- Have a positive alcohol breath test or urine screen for drugs of abuse at Screening or check-in, or evidence of drug or alcohol abuse in the investigator’s opinion.
- Have a history of or current clinically relevant condition, including social or psychiatric, which in the opinion of the investigator, precludes compliance with the protocol or otherwise makes the participant unsuitable for participation in the study.
- Have used any prescription medications within the 14 days (or 5 half-lives, whichever is longer) prior to Day 1, and/or non-prescription drugs and herbal remedies (such as St. John's Wort [Hypericum perforatum]), within the 7 days prior to Day 1, or anticipate needing to take medications during the study period.
- Have a history of prolonged use of systemic and/or high-dose inhaled corticosteroids.
- Have difficulty swallowing capsules.
- Are unwilling, unlikely or unable to comply with all protocol specified assessments.
- Have previously been randomised in this study

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306269 0
Commercial sector/Industry
Name [1] 306269 0
Amplia Therapeutics Limited
Address [1] 306269 0
Level 29, 55 Collins Street
Melbourne VIC 3000
Country [1] 306269 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Amplia Therapeutics Limited
Address
Level 29, 55 Collins Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 306758 0
None
Name [1] 306758 0
Address [1] 306758 0
Country [1] 306758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306476 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 306476 0
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 306476 0
Australia
Date submitted for ethics approval [1] 306476 0
03/08/2020
Approval date [1] 306476 0
07/09/2020
Ethics approval number [1] 306476 0

Summary
Brief summary
This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety of AMP945, and how this drug acts in the body in healthy volunteers. AMP945 may be developed for use in patients with prostate cancer, or other diseases, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed.

Who is it for?
You may be eligible for this study if you are aged 18 to 50 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer are not eligible for this study.

Study details
This trial will be conducted across three parts. In the first study (Part A), healthy volunteer participants will be assigned by chance to receive either a single dose of AMP945 or placebo, to be taken after a fasting period. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of AMP945 or placebo, followed by blood and urine testing. This will continue until 5 doses have been tested.

One group of Part A participants will return for Part B to receive either a single dose of AMP945 or placebo (same as received in Part A) immediately after a high fat meal. All participants will have their vital signs checked and will provide blood and urine samples for testing to determine the effect of food on AMP945.

In the third study (Part C), healthy volunteer participants will be assigned by chance to receive either a multiple dose of AMP945 or placebo, to be taken after a fasting period each day for 7 days. All participants will have their vital signs checked and will provide blood and urine samples for testing.

It is hoped this research will determine the doses of AMP945 that can be administered safely without causing severe reactions, and that may be effective. Once the doses of AMP945 have been determined in healthy volunteers, trials investigating the efficacy of AMP945 as a treatment for prostate cancer patients, or other diseases, may proceed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104022 0
Dr Jason Lickliter
Address 104022 0
Nucleus Network
Level 1, 484 St Kilda Road
Melbourne VIC 3004
Country 104022 0
Australia
Phone 104022 0
+61 3 9076 8906
Fax 104022 0
Email 104022 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 104023 0
Dr John Lambert
Address 104023 0
Amplia Therapeutics
Level 29, 55 Collins Street
Melbourne VIC 3000
Country 104023 0
Australia
Phone 104023 0
+61 409 525 259
Fax 104023 0
Email 104023 0
john@ampliatx.com
Contact person for scientific queries
Name 104024 0
Dr John Lambert
Address 104024 0
Amplia Therapeutics
Level 29, 55 Collins Street
Melbourne VIC 3000
Country 104024 0
Australia
Phone 104024 0
+61 409 525 259
Fax 104024 0
Email 104024 0
john@ampliatx.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a phase 1 study in healthy volunteers to guide further development plans. Individual participant results are not useful to the participants or to others outside of the sponsor. Only aggregate data may be posted/published.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary