Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The primary objective of the study is to determine the potential effects of multiple doses of rifampin and clarithromycin on the single dose pharmacokinetics (PK) of the deflazacort active metabolite (21 desacetyl-DFZ) in healthy adult subjects.
Key facts
- Study ID
- NCT02286635
- Run by
- PTC Therapeutics
- People needed
- 58
- Starts
- 2014-11-01
- Expected to finish
- 2014-12-01
- 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…
- Healthy, adult, male or female, 18 55 years of age
- Continuous non smoker who has not used nicotine containing products for at least 3 months
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2
- 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 of study drug 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 the first dose of study drug until 90 days
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 alcoholism or drug abuse within the past 2 years
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (e.g., steroids or their formulations including lactose)
- History or presence of:
- 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
- Diabetes mellitus
- Osteoporosis
- Myasthenia gravis
- Epilepsy
- Idiopathic hypocalcuria
- Hypothyroidism (TSH clinically significant)
- Gastrointestinal issues or ulcers
- Previous corticoids-induced myopathy
- Ocular herpes simplex
- Female subjects of childbearing potential
- Female subjects who are pregnant or lactating
- Positive urine drug or alcohol results
- Positive urine cotinine
- Positive results for HIV, HBsAg or HCV
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg
- Seated heart rate is lower than 40 bpm or higher than 99 bpm
- QTc interval is > 430 msec (males) or > 450 msec (females)
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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