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NCT03059303 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT03059303: Clinical Trial Phase 1 study, sponsored by Janssen Research & Development.
NCT03059303 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03059303, a Phase 1 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
Cmax is defined as the maximum observed plasma concentration.
Interventions
- DRUG Simeprevir 75 mg
- DRUG Odalasvir 25 mg
- DRUG Odalasvir 12.5 mg
- DRUG Odalasvir 75 mg
- DRUG AL-335 800 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-02-20 |
| Est. Completion | 2017-04-24 |
| Phase | Phase 1 |
Why NCT03059303 stopped before completion
NCT03059303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 5 interventions - of which Simeprevir 75 mg is the first listed.
NCT03059303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03059303 about?
NCT03059303 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT03059303?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2017-02-20. Estimated completion is 2017-04-24.
What interventions are being tested in trial NCT03059303?
The interventions under investigation include: Simeprevir 75 mg (DRUG), Odalasvir 25 mg (DRUG), Odalasvir 12.5 mg (DRUG), Odalasvir 75 mg (DRUG), AL-335 800 mg (DRUG).
Who is sponsoring clinical trial NCT03059303?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03059303's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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