Hepatitis C Clinical Trial
Official title:
Effect of a Fixed Dose Combination Formulation of Daclatasvir/Asunaprevir/BMS-791325 on the Pharmacokinetics of a Cocktail of CYP Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, and Midazolam) and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3 direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325 75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter probe substrates.
IND number: 79,599 and 101,943
Primary purpose: Other: study is being conducted to investigate the potential drug-drug
interactions (DDIs) when the Daclatasvir/Asunaprevir/BMS-791325 FDC formulation is
coadministered with a cocktail of cytochrome P450 (CYP) probe substrates (Caffeine,
Metoprolol, Montelukast, Flurbiprofen, Omeprazole, and Midazolam) and transporter probe
substrates (Digoxin and Pravastatin) in healthy subjects. It is also intended to
characterize the PK of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325, and its major
metabolite, BMS-794712, at steady state.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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