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NCT02286622 · ClinicalTrials.gov registry record · Phase 1
A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics
A Phase 1 study of Renal Impairment, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT02286622 is a Phase 1 study of Renal Impairment that has completed, run by PTC Therapeutics. The registered enrollment target is 16 participants, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02286622, a Phase 1 study of Renal Impairment, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched control subjects (age, body mass index \[BMI\], and gender).
Conditions Studied
Interventions
- DRUG Deflazacort
Study Locations (2)
Florida
- University of Miami Division of Clinical Pharmacology - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02286622
The ClinicalTrials.gov registry entry for NCT02286622 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (53% lower). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which Deflazacort is the first listed.
NCT02286622 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02286622 about?
NCT02286622 is a clinical study titled "A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics". This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched control subjects (age, body mass index \[BMI\], and gender).
What is the current status of trial NCT02286622?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-12. Estimated completion is 2015-02.
What conditions does trial NCT02286622 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT02286622?
The interventions under investigation include: Deflazacort (DRUG).
Who is sponsoring clinical trial NCT02286622?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02286622 being conducted?
This trial has 2 study locations across Florida. 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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