Doravirine
DrugFollowing an overnight fast, a single tablet of 100 mg doravirine was be administered orally
Other names: MK-1439
NCT Number: NCT02089659
This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally
Other names: MK-1439
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, and 24 hours postdose
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method
Time frame: 24 hours postdose
Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method
Merck Sharp & Dohme LLC
Industry
A 2-Part, Open-Label, Singe-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439
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