Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01077167

Pharmacokinetic Study of Omecamtiv Mecarbil in Heart Failure Patients

An Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of Omecamtiv Mecarbil Administered Orally to Patients With Stable Heart Failure

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Cytokinetics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this trial is to obtain a pharmacokinetic profile (i.e. amount of drug in the blood over time) of Omecamtiv mecarbil in patients with stable heart failure.

Detailed description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions

Interventions

TypeNameDescription
DRUGOmecamtiv mecarbilOral dosing twice each day or three times each day, depending on the cohort assignment, of Omecamtiv mecarbil for 8 days. Omecamtiv mecarbil comes in 2 formulations: modified release and immediate release, and the formulation given will depend on the cohort assignment.

Timeline

Start date
2010-07-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2010-02-26
Last updated
2021-07-30

Source: ClinicalTrials.gov record NCT01077167. Inclusion in this directory is not an endorsement.