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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 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 72 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03059303
The ClinicalTrials.gov registry entry for NCT03059303 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Simeprevir 75 mg is the first listed.
NCT03059303 reports 0 study locations.
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.
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