A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Hepatic Impairment
Interventions
DRUG

Deflazacort

Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite, 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone.

Trial Locations (2)

32809

Orlando Clinical Research Center, Orlando

33136

University of Miami Division of Clinical Pharmacology, Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PTC Therapeutics

INDUSTRY