drugset / Trial / NCT02341599

Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)

NCT02341599 ↗

Phase 1 Completed 40 enrolled Merck & Co., Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans. The study will also assess the safety profile and tolerability of MK-6183 in healthy participants, participants with varying degrees of renal impairment (RI), or participants with end-stage renal disease (ESRD) requiring hemodialysis (HD), based on estimated glomerular filtration rate (eGFR).

Timeline

Start
2014-12-11
Primary completion
2015-04-13
Completion
2015-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-6183 Unknown — Intravenous