Conditions: Healthy Volunteers Renal Impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief 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).

Detailed description:

Arms:
arm 1: Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2). arm 2: Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2). arm 3: Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2). arm 4: Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2) not receiving HD. arm 5: Participants with ESRD who are receiving HD for at least 3 months preceding the initial dose in this study (Stage 5).

Interventions: intervention 1: MK-6183
Intervention descriptions: intervention 1: MK-6183 (CB-238,614) is supplied as lyophilized powder 500 mg vial and mixed into solution for 100 mL intravenous (IV) administration over 1 hour.

Protocol document: