An open-label, food-effect PK study on Omecamtiv Mecarbil
Research type
Research Study
Full title
A Two-part, Open-label, Randomized, Crossover Study to Assess the Pharmacokinetics of Various Omecamtiv Mecarbil Formulations in Healthy Subjects
IRAS ID
272524
Contact name
Samuel Israel
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2019-003683-44
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC Reference, 20/NW/0014
Duration of Study in the UK
years, 5 months, days
Research summary
The name of the study drug is Omecamtiv mecarbil, which belongs to the class of compounds known to increase cardiac contractility by selectively and directly activating the enzymatic domain of cardiac myosin heavy chain, the force generating motor protein of the cardiac sarcomere, without increasing cardiac myocyte intracellular calcium.
The Study Drug is an investigational drug being developed with the aim of helping people with heart failure and has been investigated in 11 phase 1 studies 4 phase 2a studies in subjects with heart failure. In these studies, the efficacy, safety, tolerability, PK, and PD of omecamtiv mecarbil were evaluated extensively.
The currently available treatments for this condition have side effects, and it is hoped that the study drug will have fewer side effects. The planned study is designed as a two part, open label, randomised cross over study to access the pharmacokinetics of various formulations of Omecamtiv mecarbil in healthy subjects given under fed and fasted states as a two-part study. In Part A, the design is a 5 period sequence complete cross-over study, and will be conducted at a site in the United States of America to investigate the effect of food on PK of two different MR (modified release) tablet strengths of OM (25mg and 37.5mg) in healthy subjects. In addition, the PK of OM given as an oral solution will be evaluated.
Part B of the study will consist of 32 volunteers and will be conducted at the Covance Clinical Research unit in Leeds UK, and will be a 3-period, 3-sequence cross over study, to evaluate PK data of 3 different tablet treatments and an immediate release oral solution treatment to support possible future studies.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0014
Date of REC Opinion
3 Mar 2020
REC opinion
Further Information Favourable Opinion