drugset / Trial / NCT03059303
Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the relative bioavailability of single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 when administered as a fixed-dose combination (FDC) compared with the single agents when administered together, and to assess the effect of multiple-dose lansoprazole and omeprazole on the single-dose pharmacokinetics (PK) of SMV, ODV, and AL-335 when administered as an FDC.
Timeline
- Start
- 2017-02-20
- Primary completion
- 2017-04-24
- Completion
- 2017-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADAFOSBUVIR | Small molecule | 800 mg | Oral |
| Subject | Lansoprazole | Other / unclassified | 30 mg | — |
| Subject | Odalasvir | Small molecule | 12.5 mg | Oral |
| Subject | Odalasvir | Small molecule | 25 mg | Oral |
| Subject | Odalasvir | Small molecule | 75 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |
| Subject | Simeprevir | Small molecule | 75 mg | Oral |
Indications
No indication recorded.