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NCT02486055 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of Orally Administered BPM31510 in Healthy Subjects
A Phase 1 study, sponsored by BPGbio.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02486055: Completed Phase 1 study, sponsored by BPGbio.
NCT02486055 is a Phase 1 study that has completed, run by BPGbio. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02486055, a Phase 1 study, has completed, sponsored by BPGbio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts may be enrolled sequentially.
Primary Outcome
PK parameters maximum plasma concentration (Cmax) and area under the plasma concentration curve from 0 to 4 hours (AUC0-4) on Days 1, 2, 8, and 15; baseline pre-dosing concentrations.
Interventions
- DRUG BPM31510 Oral Nanosuspension 4%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT02486055 record still lists
NCT02486055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which BPM31510 Oral Nanosuspension 4% is the first listed.
NCT02486055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02486055 about?
NCT02486055 is a clinical study titled "A Safety Study of Orally Administered BPM31510 in Healthy Subjects". This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration....
What is the current status of trial NCT02486055?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02486055?
The interventions under investigation include: BPM31510 Oral Nanosuspension 4% (DRUG).
Who is sponsoring clinical trial NCT02486055?
This trial is sponsored by BPGbio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02486055's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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