A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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).
Key facts
- Study ID
- NCT02286609
- Run by
- PTC Therapeutics
- People needed
- 16
- Starts
- 2014-12-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2017-08-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All Subjects
- Continuous non-smokers or moderate smokers.
- For a female of non-childbearing potential: must have undergone one a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to dosing and FSH serum levels consistent with postmenopausal status
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days
- If male, must agree not to donate sperm from dosing until 90 days Subject with Moderate Hepatic Impairment
- Adult male or female, 18 80 years of age
- BMI ≥ 18.5 and ≤ 40.0 kg/m2
- Subject's score on the Child-Pugh scale must range from 7 to 9 (moderate hepatic insufficiency)
- Subject has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology.
- Healthy Subject
- Healthy adult male and female subjects will be matched 1:1 to a specific subject in the moderate hepatic impairment cohort based upon age, BMI, and gender.
You may not qualify if…
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds (e.g., steroids or their formulations including lactose and corn starch).
- History (within the last year prior to dosing) or presence of peptic ulcers.
- History or presence of:
- Gastritis or esophagitis, diverticulitis, ulcerative colitis (if there is probability of impending perforation), abscess or pyogenic infections, or fresh intestinal anastomosis;
- Previous corticoids-induced myopathy;
- Ocular herpes simplex;
- Symptomatic cardiomyopathy at screening;
- Immunosuppression or other contraindications for corticosteroid treatment;
- History of chronic systemic fungal or viral infections;
- Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption;
- Osteoporosis;
- Myasthenia gravis;
- Epilepsy;
- Idiopathic hypocalcuria.
- Seated blood pressure is less than 90/40 mmHg or greater than 160/95 mmHg
- Seated heart rate is lower than 40 bpm or higher than 99 bpm
- QTcF interval is > 500 msec
- Has received any live or live-attenuated vaccine within 30 days
- Has received any immunosuppressive agents, coal tar, and/or radiation therapies within 30 days
- Has received injectable corticoids in the 12 weeks prior to dosing or any oral form of corticoids in 30 days
- Unable to refrain from or anticipates the use of:
- Any drug known to be moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A or P-glycoprotein (P-gp) for 14 days or 28 days, respectively
- Any medication or substance, vitamin supplements, natural or herbal supplements which cannot be discontinued at least 14 days
- Female subjects of childbearing potential.
Where it is running
- University of Miami Division of Clinical Pharmacology — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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