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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02485431
The ClinicalTrials.gov registry entry for NCT02485431 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (91% lower). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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