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NCT04156646 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04156646: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT04156646 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04156646, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
Primary Outcome
Maximum plasma concentration of Balovaptan is estimated using non-compartmental methods. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units
Interventions
- DRUG Esomeprazole
- DRUG Balovaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 1 |
What the finished NCT04156646 record still lists
NCT04156646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.
NCT04156646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04156646 about?
NCT04156646 is a clinical study titled "A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers". This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
What is the current status of trial NCT04156646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-11-19. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT04156646?
The interventions under investigation include: Esomeprazole (DRUG), Balovaptan (DRUG).
Who is sponsoring clinical trial NCT04156646?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04156646's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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