drugset / Trial / NCT01926509

Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005)

NCT01926509 ↗

Phase 1 Completed 23 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892 area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr.

Timeline

Start
2013-11-14
Primary completion
2014-09-01
Completion
2014-09-08

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8892 Unknown 4 mg Oral
Subject MK-8892 Unknown 8 mg Oral