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NCT03155893 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT03155893: Completed Phase 1 study of Healthy, sponsored by Janssen Research & Development.
NCT03155893 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 59 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03155893, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy participants.
Primary Outcome
Intersection-union test (IUT) analysis will be performed to evaluate the effect of AL-335 on QT/QTc interval changes after a single supratherapeutic dose of AL-335 on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo.
Conditions Studied
Interventions
- DRUG ODV Placebo (Matching 25 mg ODV)
- DRUG ODV Placebo (Matching 200 mg ODV)
- DRUG ODV Placebo (Matching 125 mg ODV)
- DRUG ODV Placebo (Matching 100 mg ODV)
- DRUG SMV Placebo (Matching 150 mg SMV)
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2017-05-12 |
| Est. Completion | 2017-10-27 |
| Phase | Phase 1 |
What the finished NCT03155893 record still lists
NCT03155893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which ODV Placebo (Matching 25 mg ODV) is the first listed.
NCT03155893 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03155893 about?
NCT03155893 is a clinical study titled "A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants". The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analy...
What is the current status of trial NCT03155893?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2017-05-12. Estimated completion is 2017-10-27.
What conditions does trial NCT03155893 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03155893?
The interventions under investigation include: ODV Placebo (Matching 25 mg ODV) (DRUG), ODV Placebo (Matching 200 mg ODV) (DRUG), ODV Placebo (Matching 125 mg ODV) (DRUG), ODV Placebo (Matching 100 mg ODV) (DRUG), SMV Placebo (Matching 150 mg SMV) (DRUG).
Who is sponsoring clinical trial NCT03155893?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03155893 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03155893's enrollment target sits among peer trials
59 403rd of 1090 higher than 685 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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