Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marathon Pharmaceuticals, LLC; PTC Therapeutics
• Treatments: Clarithromycin; Deflazacort; Rifampin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Symptomatic cardiomyopathy at screening

2. Immunosuppression or other contraindications for corticosteroid treatment

3. History of chronic systemic fungal or viral infections

4. Galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption

5. Diabetes mellitus

6. Osteoporosis

7. Myasthenia gravis

8. Epilepsy

9. Idiopathic hypocalcuria

10. Hypothyroidism (TSH clinically significant)

11. Gastrointestinal issues or ulcers

12. Previous corticoids-induced myopathy

13. 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)

• 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 dose of study drug or any oral form of corticoids in 30 days

• Estimated creatinine clearance < 80 ml/min

• Unable to refrain from or anticipates the use of

• Any drug, including prescription and non prescription medications, as well as herbal remedies known to be significant inhibitors of CYP 3A4 enzymes and/or P gp for 14 days

• Any drugs known to be significant inducers of CYP 3A4 enzymes and/or P gp, including St. John's Wort, for 28 days

• Have 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