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About
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
Full description
Study Design:
This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants).
Part II will be conducted only if the primary hypothesis is not met and there is a significant difference in the PK of suvorexant between healthy participants and moderate hepatic insufficiency participants in Part I.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria for Hepatic Insufficiency Participants:
Inclusion Criteria for Healthy Matched Participants:
Exclusion Criteria for Hepatic Insufficiency Participants:
months
respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
Exclusion Criteria for Healthy Matched Participants:
cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
Primary purpose
Allocation
Interventional model
Masking
16 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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