drugset / Trial / NCT03295266

Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)

NCT03295266 ↗

Phase 1 Terminated 9 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy participants. The primary purpose of this study is to understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing recommendations for participants with HI. This study will also evaluate the safety and tolerability of MK-3866 in participants with moderate and severe HI.

Timeline

Start
2017-12-19
Primary completion
2018-03-15
Completion
2018-03-15

Outcome

Outcome not reported

Stopped (Business): “Business and program changes”

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-3866 Unknown 150 mg Intravenous

Indications