drugset / Trial / NCT03277755
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function
Non-randomizedParallel-groupOpen-labelOther
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV) and its metabolites ALS-022399 and ALS-022227, after a single oral dose of ODV and AL-335 respectively, in participants with moderately impaired hepatic function compared to participants with normal hepatic function. Also to evaluate the steady-state PK of AL-335 and its metabolites ALS-022399 and ALS-022227, ODV and simeprevir (SMV) after multiple oral doses of the combination of AL-335+ODV+SMV, in participants with moderately impaired hepatic function compared to participants with normal hepatic function.
Timeline
- Start
- 2017-09-11
- Primary completion
- 2017-12-22
- Completion
- 2017-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADAFOSBUVIR | Small molecule | 800 mg | Oral |
| Subject | Odalasvir | Small molecule | 25 mg | Oral |
| Subject | SMV | Unknown | 75 mg | Oral |
Indications
No indication recorded.