Phase 1, Open-label, Partially Randomized, Parallel-group Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 Administered as a Fixed-dose Combination (FDC) Compared With the Single Agents Administered Together, and to Assess the Effect of Multiple-dose Lansoprazole or Omeprazole on the Single-dose Pharmacokinetics of SMV, ODV, and AL-335 Administered as an FDC
Phase of Trial: Phase I
Latest Information Update: 22 Jun 2017
At a glance
- Drugs AL 335/odalasvir/simeprevir (Primary) ; Lansoprazole; Omeprazole
- Indications Hepatitis C
- Focus Pharmacokinetics
- Sponsors Janssen Research & Development
- 13 Jun 2017 Planned End Date changed from 10 Oct 2017 to 17 Oct 2017.
- 13 Jun 2017 Planned primary completion date changed from 10 May 2017 to 17 Oct 2017.
- 17 Mar 2017 Planned End Date changed from 1 May 2017 to 10 Oct 2017.