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NCT05160389 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
A Phase 1 study of Food Effect in Healthy Volunteers, sponsored by Pyramid Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05160389: Completed Phase 1 study of Food Effect in Healthy Volunteers, sponsored by Pyramid Biosciences.
NCT05160389 is a Phase 1 study of Food Effect in Healthy Volunteers that has completed, run by Pyramid Biosciences. 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05160389, a Phase 1 study of Food Effect in Healthy Volunteers, has completed, sponsored by Pyramid Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
Primary Outcome
Tmax will be determined from the observed plasma concentration data.
Conditions Studied
Interventions
- DRUG PBI-200
Study Locations (1)
Missouri
- Bio-Kinetic Clinical Applications - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2022-01-06 |
| Phase | Phase 1 |
What the finished NCT05160389 record still lists
NCT05160389 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 1 condition, with Food Effect in Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which PBI-200 is the first listed.
NCT05160389 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05160389 about?
NCT05160389 is a clinical study titled "A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200". This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
What is the current status of trial NCT05160389?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-11-17. Estimated completion is 2022-01-06.
What conditions does trial NCT05160389 study?
This clinical trial studies the following conditions: Food Effect in Healthy Volunteers.
What interventions are being tested in trial NCT05160389?
The interventions under investigation include: PBI-200 (DRUG).
Who is sponsoring clinical trial NCT05160389?
This trial is sponsored by Pyramid Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05160389 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05160389'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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