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NCT04138836 · ClinicalTrials.gov registry record · Phase 1
Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects
A Phase 1 study of Healthy Participants, sponsored by Bridge Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04138836: Completed Phase 1 study of Healthy Participants, sponsored by Bridge Biotherapeutics.
NCT04138836 is a Phase 1 study of Healthy Participants that has completed, run by Bridge Biotherapeutics. The registered enrollment target is 48 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138836, a Phase 1 study of Healthy Participants, has completed, sponsored by Bridge Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetics of BBT-877, in healthy adult subjects.
Primary Outcome
AUC for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3)
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Itraconazole
- DRUG Esomeprazole
- DRUG BBT-877
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 1 |
What the finished NCT04138836 record still lists
NCT04138836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Healthy Participants appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT04138836 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT04138836 about?
NCT04138836 is a clinical study titled "Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects". Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetic...
What is the current status of trial NCT04138836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-09-17. Estimated completion is 2019-11-04.
What conditions does trial NCT04138836 study?
This clinical trial studies the following conditions: Healthy Participants.
What interventions are being tested in trial NCT04138836?
The interventions under investigation include: Midazolam (DRUG), Itraconazole (DRUG), Esomeprazole (DRUG), BBT-877 (DRUG).
Who is sponsoring clinical trial NCT04138836?
This trial is sponsored by Bridge Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04138836 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Participants
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 NCT04138836's enrollment target sits among peer trials
48 51st of 119 higher than 67 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants 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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