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NCT02889367 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02889367 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02889367, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Odalasvir 100 mg
- DRUG Odalasvir 500 mg
- DRUG Odalasvir (Up to maximum 1000 mg)
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-09-12 |
| Est. Completion | 2017-03-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02889367
The ClinicalTrials.gov registry entry for NCT02889367 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02889367 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT02889367 about?
NCT02889367 is a clinical study titled "A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants". The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
What is the current status of trial NCT02889367?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2016-09-12. Estimated completion is 2017-03-04.
What conditions does trial NCT02889367 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02889367?
The interventions under investigation include: Placebo (DRUG), Odalasvir 100 mg (DRUG), Odalasvir 500 mg (DRUG), Odalasvir (Up to maximum 1000 mg) (DRUG).
Who is sponsoring clinical trial NCT02889367?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02889367 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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