Single-dose randomized study of Omecamtiv Mecarbil in healthy subjects
Research type
Research Study
Full title
Single-dose and Randomized, Single-center, Placebo- and Active controlled, Crossover Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Subjects
IRAS ID
266633
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2018-003157-19
Clinicaltrials.gov Identifier
19/NW/0449, REC reference number
Duration of Study in the UK
1 years, 3 months, 9 days
Research summary
Omecamtiv mecarbil (OM) is a novel small molecule that increases cardiac contractility. It is hoped that Omecamtiv Mecarbil may be useful in the treatment of heart failure patients in the future.
This is a single-centre, single-dose (Part A; PK Evaluation Period), and randomized, 3-period, 3 treatment, crossover, single-dose (Part B) study in healthy adult subjects to determine whether OM prolongs the QTc value on ECGs after a single oral dose administration of 50 mg OM.
Treatment in Part A will consist of a single 25-mg OM treatment (Treatment 1). Subjects whose resulting maximum observed plasma OM concentration (Cmax) is ≤ 350 ng/mL will be randomized into Part B, which consists of 3 periods wherein a single dose treatment is given in each period. Treatments in Part B will consist of placebo (Treatment A), OM 50 mg (Treatment B), or moxifloxacin 400 mg (Treatment C). The dosing sequence in Part B will be randomised. All treatments (Part A and Part B) will be separated by a washout of at least 7 days.
In Part A, subjects will be resident in the unit from Day-1 until Day 3 and will return for a safety follow-up visit on Day 6. In Part B, eligible subjects will remain resident in the unit continuously from Day-1 of Period 1 until Day 6 of Period 3 (the day of their safety follow-up assessments).
Approximately 60 to 70 subjects will be enrolled in Part A in order to have 60 subjects (10 per sequence) enrolled in Part B.
The planned study duration for subjects who participate in Parts A and B will be approximately 7 weeks. For subjects who participate in Part A only the study duration will be approximately 5 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0449
Date of REC Opinion
21 Oct 2019
REC opinion
Further Information Favourable Opinion