Conditions: Insomnia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: yes

Brief summary:
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants.

Detailed description:
Study Design:

This study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal impairment and a control group of 8 healthy participants).

Part II will be conducted only if the primary hypothesis is not met in Part I and there is a significant difference in the PK of suvorexant between healthy participants and severe renal impairment participants.

Arms:
arm 1: Participants with severe renal impairment will receive a

single dose of 20 mg open-label suvorexant during Part I of the

study. arm 2: Healthy participants matched to participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 3: Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 4: Healthy participants matched to participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 5: Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 6: Healthy participants matched to participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.

Interventions: intervention 1: Suvorexant
Intervention descriptions: intervention 1: single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \~240 mL of water after an 8 hour fast

Protocol document: