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NCT03808298 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT03808298: Completed Phase 1 study of Healthy Volunteers, sponsored by Hoffmann-La Roche.
NCT03808298 is a Phase 1 study of Healthy Volunteers that has completed, run by Hoffmann-La Roche. The registered enrollment target is 57 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03808298, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy subjects.
Primary Outcome
Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.
Conditions Studied
Interventions
- DRUG Balovaptan therapeutic dose Treatment A
- DRUG Balovaptan supra-therapeutic dose Treatment B
- DRUG Active control [moxifloxacin] on Day 2 Treatment C
- DRUG Active control [Moxifloxacin] on Day 15 Treatment D
- DRUG Placebo for Balovaptan Treatment C
Study Locations (1)
Kansas
- PRA International Clinical Pharmacology Center (EDS US Clinic) - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2019-07-13 |
| Phase | Phase 1 |
What the finished NCT03808298 record still lists
NCT03808298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Balovaptan therapeutic dose Treatment A is the first listed.
NCT03808298 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT03808298 about?
NCT03808298 is a clinical study titled "Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects". This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy subjects.
What is the current status of trial NCT03808298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2019-02-07. Estimated completion is 2019-07-13.
What conditions does trial NCT03808298 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03808298?
The interventions under investigation include: Balovaptan therapeutic dose Treatment A (DRUG), Balovaptan supra-therapeutic dose Treatment B (DRUG), Active control [moxifloxacin] on Day 2 Treatment C (DRUG), Active control [Moxifloxacin] on Day 15 Treatment D (DRUG), Placebo for Balovaptan Treatment C (DRUG).
Who is sponsoring clinical trial NCT03808298?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03808298 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03808298's enrollment target sits among peer trials
57 127th of 283 higher than 156 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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