ANZCTR - Registration

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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

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]

AMP945-101

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pancreatic cancer

Idiopathic pulmonary fibrosis

Condition category

Condition code

Cancer

Pancreatic

Respiratory

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]

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]

Safety and tolerability will be assessed by vital signs, clinical safety labs, electrocardiograms (ECGs), physical exams and adverse events.

Timepoint [1]

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]

Plasma pharmacokinetics of AMP945, including AUC, Tmax, Cmax, T1/2

Timepoint [1]

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]

Urine pharmacokinetics of AMP945, including absorption and elimination

Timepoint [2]

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

Sex

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

1/10/2020

Actual

30/09/2020

Date of last participant enrolment

Anticipated

Actual

1/04/2021

Date of last data collection

Anticipated

Actual

12/07/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Amplia Therapeutics Limited

Address [1]

Level 29, 55 Collins Street
Melbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Rd
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/08/2020

Approval date [1]

07/09/2020

Ethics approval number [1]

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

Dr Jason Lickliter

Address

Nucleus Network
Level 1, 484 St Kilda Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9076 8906

Fax

j.lickliter@nucleusnetwork.com.au

Contact person for public queries

Name

John Lambert

Address

Amplia Therapeutics
Level 29, 55 Collins Street
Melbourne VIC 3000

Country

Australia

Phone

+61 409 525 259

Fax

john@ampliatx.com

Contact person for scientific queries

Name

John Lambert

Address

Amplia Therapeutics
Level 29, 55 Collins Street
Melbourne VIC 3000

Country

Australia

Phone

+61 409 525 259

Fax

john@ampliatx.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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