* Study of the Bioavailability, PK and PD of ACM-001.1 and Pindolol
Research type
Research Study
Full title
A Two Part Study to Assess the Comparative Bioavailability and Pharmacokinetics of a Single Dose of ACM-001.1 and Two Single Doses of Pindolol (Part 1) Followed by an Evaluation of the Steady State Pharmacokinetics and Pharmacodynamics of ACM-001.1 in Healthy Volunteers (Part 2)
IRAS ID
303412
Contact name
Elaine Morten
Contact email
Sponsor organisation
Actimed Therapeutics Ltd
Eudract number
2021-004146-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 28 days
Research summary
The Sponsor is developing a new medicine called ACM-001.1 which is closely related to an approved medicine called Pindolol. Pindolol belongs to a group of medicines called beta blockers and is a marketed medicine that is used for the treatment of high blood pressure and chest pain due to angina (reduced blood flow to the heart muscles). ACM-001.1, the test medicine, is being developed with the aim to treat cancer cachexia. \n\nCachexia is a complex change in the body causing a loss in weight despite eating normally. It is more than only loss of appetite, it can involve changes in the way the body uses proteins, carbohydrates and fat. \n\nThis is a 2-Part, single-centre study in healthy male and non-pregnant, non-lactating female volunteers, aged between 20 and 45. The aim of this study is to compare the test medicine to the marketed medicine to see how it is taken up and removed by the body and also to investigate the safety and tolerability when taken as a single or twice daily oral dose. \n\nPart 1 is a part-blinded, part-randomised study involving two groups of volunteers. Group 1 (16 volunteers) will receive a single dose of the test medicine and Pindolol 48 hours apart. Group 2 (8 volunteers) will receive a single dose of Pindolol only. All subjects will be dosed in the fasted state. Volunteers will be discharged 24 hours post-final dose and will receive a follow-up phone call 2–4 days post-final dose.\n\nPart 2 is a subject blinded, randomised study where 4 groups of 8 volunteers will receive the test medicine (at different dose levels) or Pindolol, twice daily for Days 1-3 and once on Day 4 in the fed state. Volunteers will be discharged 3 days post-final dose and will receive a follow-up phone call 5-7 days post-final dose.\n
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0183
Date of REC Opinion
28 Oct 2021
REC opinion
Favourable Opinion