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NCT02286635 · ClinicalTrials.gov registry record · Phase 1
Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort
A Phase 1 study of Healthy Volunteers, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02286635: Completed Phase 1 study of Healthy Volunteers, sponsored by PTC Therapeutics.
NCT02286635 is a Phase 1 study of Healthy Volunteers that has completed, run by PTC Therapeutics. The registered enrollment target is 58 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02286635, a Phase 1 study of Healthy Volunteers, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to determine the potential effects of multiple doses of rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort active metabolite (21 desacetyl-DFZ) in healthy adult subjects.
Primary Outcome
Effects of CYP3A4 inhibitors and inducers on the pharmacokinetics (PK) of deflazacort in healthy subjects including the area under the plasma concentration time curve, from time 0 to the last measurable non-zero concentration.
Conditions Studied
Interventions
- DRUG Deflazacort and rifampin
- DRUG Deflazacort and Clarithromycin
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02286635 record still lists
NCT02286635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Deflazacort and rifampin is the first listed.
NCT02286635 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02286635 about?
NCT02286635 is a clinical study titled "Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort". The primary objective of the study is to determine the potential effects of multiple doses of rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort active metabolite (21 desacetyl-DFZ) in healthy adult subjects.
What is the current status of trial NCT02286635?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2014-11. Estimated completion is 2014-12.
What conditions does trial NCT02286635 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02286635?
The interventions under investigation include: Deflazacort and rifampin (DRUG), Deflazacort and Clarithromycin (DRUG).
Who is sponsoring clinical trial NCT02286635?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02286635 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
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 NCT02286635's enrollment target sits among peer trials
58 124th of 283 higher than 158 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.
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