drugset / Trial / NCT01380223
A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil infusion in healthy male volunteers.
Timeline
- Start
- 2005-08
- Primary completion
- 2006-04
- Completion
- 2006-04
Publications
- Vu T, Ma P, Xiao JJ, Wang YM, Malik FI, Chow AT. Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure. J Clin Pharmacol. 2015 Nov;55(11):1236-47. doi: 10.1002/jcph.538. Epub 2015 Jul 14.
- Teerlink JR, Clarke CP, Saikali KG, Lee JH, Chen MM, Escandon RD, Elliott L, Bee R, Habibzadeh MR, Goldman JH, Schiller NB, Malik FI, Wolff AA. Dose-dependent augmentation of cardiac systolic function with the selective cardiac myosin activator, omecamtiv mecarbil: a first-in-man study. Lancet. 2011 Aug 20;378(9792):667-75. doi: 10.1016/S0140-6736(11)61219-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omecamtiv Mecarbil | Small molecule | 0.005 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.015 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.025 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.0625 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.125 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.25 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.625 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 0.75 mg/kg | Intravenous |
| Subject | Omecamtiv Mecarbil | Small molecule | 1 mg/kg | Intravenous |