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

Phase 1

Completed

• Conditions: Pancreatic cancer; Idiopathic pulmonary fibrosis; Cancer - Pancreatic; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000894998
• Lead Sponsor: Amplia Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Study Completion: 2021-07-12
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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

• Study Type: Interventional
• Study Design: Not specified