None listed
Conditions
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.
Interventions
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% f
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
Sponsors
Amplia Therapeutics Limited
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Outcome results
None listed