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NCT02485431 · ClinicalTrials.gov registry record · Phase 1
Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT02485431: Completed Phase 1 study of Healthy Volunteers, sponsored by PTC Therapeutics.
NCT02485431 is a Phase 1 study of Healthy Volunteers that has completed, run by PTC Therapeutics. The registered enrollment target is 45 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02485431, a Phase 1 study of Healthy Volunteers, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed to assess the comparative bioavailability and food effect of deflazacort. A total of 45 subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and all subjects will receive all 5 treatments in a crossover fashion.
Primary Outcome
Pharmacokinetic parameters such as the maximum observed plasma concentration (Cmax), time to Cmax (Tmax), the area under the plasma concentration versus time curve from time 0 (predose) to the last quantifiable time point (AUClast), AUC from time 0 (predose) to time infinity (AUCinf), the elimination rate constant (λz), and terminal elimination half-life (t½) will be calculated
Conditions Studied
Interventions
- DRUG Deflazacort
Study Locations (1)
Texas
- ICON Early Phase Services - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT02485431 record still lists
NCT02485431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Deflazacort is the first listed.
NCT02485431 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02485431 about?
NCT02485431 is a clinical study titled "Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers". This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed to assess the comparative bioavailability and food effect of deflazacort. A total of 45 subjects will be randomly assigned to receive 1 of 5 treatment sequences. Each dosing sequence will be enrolled in para...
What is the current status of trial NCT02485431?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2015-06. Estimated completion is 2015-08.
What conditions does trial NCT02485431 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02485431?
The interventions under investigation include: Deflazacort (DRUG).
Who is sponsoring clinical trial NCT02485431?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02485431 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02485431's enrollment target sits among peer trials
45 147th of 283 higher than 137 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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