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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 is a Phase 1 study that has completed, run by PTC Therapeutics. The registered enrollment target is 16 participants.
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).
Interventions
- DRUG Deflazacort
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 NCT02286609
The ClinicalTrials.gov registry entry for NCT02286609 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. The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Deflazacort is the first listed.
NCT02286609 reports 0 study locations.
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.
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