Status:
COMPLETED
A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics
Lead Sponsor:
PTC Therapeutics
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 (a...
Detailed Description
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 (a...
Eligibility Criteria
Inclusion
- Continuous non-smokers or moderate smokers
- For a female of non-childbearing potential: must have undergone a sterilization procedures or be postmenopausal with amenorrhea for at least 1 year prior to the first dose 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 ESRD on Hemodialysis
- Adult male or female, 18 80 years of age
- BMI ≥ 18.5 and ≤ 40.0 kg/m2 - Subject is maintained on a stable regimen of HD at least 3 months Healthy Subject
- Healthy adult male and female subjects will be matched 1:1 to a specific subject in the ESRD cohort based upon age, BMI, and gender \[1:1\]. The following criteria should be fulfilled:
- 18 to 80 years of age. Age must be within ± 15 years of the matched subject's age in the ESRD cohort
- BMI ≥ 18.5 and ≤ 40.0 kg/m2. BMI must be within ± 15% of the matched subject's BMI in the ESRD cohort
- Has a CLcr ≥ 90 mL/min
Exclusion
- 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 drugs or related compounds (e.g., steroids or their formulations including lactose and corn starh)
- 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 170/100 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 which cannot be discontinued at least 14 days
- Female subjects of childbearing potential
- Female subjects who are pregnant or lactating
- Positive results at screening for HIV, HBsAg or HCV
- Has been on a diet incompatible with the on study diet within 28 days
- Donation of blood or significant blood loss within 56 days
- Plasma donation within 7 days
- Participation in another clinical trial within 28 days Subject with ESRD
- Is a regular user of any medication that would significantly alter glomerular filtration rate, e.g., cimetidine
- Has presence of a renal carcinoma or acute renal disease caused by infection or drug toxicity
- History of drug abuse within the past 2 years
- Has a positive urine/breath alcohol or urine/serum/saliva drug testing Normal Renal Function
- History or presence of alcoholism or drug abuse within the past 2 years
- Positive urine drug or urine/breath alcohol results
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02286622
Start Date
December 1 2014
End Date
February 1 2015
Last Update
August 18 2017
Active Locations (2)
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1
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States, 33136
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809