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NCT02286609 · ClinicalTrials.gov registry record · Phase 1
A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics
A Phase 1 study, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02286609: Completed Phase 1 study, sponsored by PTC Therapeutics.
NCT02286609 is a Phase 1 study that has completed, run by PTC Therapeutics. 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02286609, a Phase 1 study, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
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 moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index \[BMI\], and gender).
Primary Outcome
Hepatic impairment on the pharmacokinetics (PK) of deflazacort in subjects with moderate hepatic impairment including the area under the plasma concentration time curve, from time 0 to the last measurable non-zero concentration.
Interventions
- DRUG Deflazacort
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT02286609 record still lists
NCT02286609 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 0 conditions, and to 1 intervention - of which Deflazacort is the first listed.
NCT02286609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02286609 about?
NCT02286609 is a clinical study titled "A Single Dose Evaluation of the Effects of Moderate Hepatic 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 moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index \[BMI\]...
What is the current status of trial NCT02286609?
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 interventions are being tested in trial NCT02286609?
The interventions under investigation include: Deflazacort (DRUG).
Who is sponsoring clinical trial NCT02286609?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02286609'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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