drugset / Trial / NCT02045966
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
NaSingle-groupOpen-label
Summary
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.
Timeline
- Start
- 2014-02
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASV | Unknown | 200 mg | Oral |
| Subject | Beclabuvir | Small molecule | 75 mg | Oral |
| Subject | Caffeine | Small molecule | 200 mg | Oral |
| Subject | DCV | Unknown | 30 mg | Oral |
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Flurbiprofen | Small molecule | 50 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 50 mg | Oral |
| Subject | Midazolam | Small molecule | 5 mg | Oral |
| Subject | Montelukast | Other / unclassified | 10 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |
| Subject | Pravastatin | Small molecule | 40 mg | Oral |