Crossover Drug-Drug Interaction Study to Determine Effects of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/24/2018 |
Start Date: | August 16, 2017 |
End Date: | November 29, 2017 |
A Phase 1, Open-Label, Fixed-Sequence, Crossover Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inducer of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
This is a Phase 1, single center, fixed sequence, open label, drug-drug interaction study of
the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the
exposure of mifepristone at 2 dose levels.
the effect of multiple doses of rifampin 600 mg daily, a strong CYP3A inducer, on the
exposure of mifepristone at 2 dose levels.
Inclusion Criteria:
- Be healthy
- Have a BMI of 18 to 32 kg/m2, inclusive, and body weight more than 50 kg (110 pounds)
- Be judged to be in good health, based on the results of medical history, physical
examination, vital signs, 12-lead ECG, and clinical laboratory findings
- Have suitable veins for multiple venipuncture/cannulation
- Female subjects of childbearing potential must use highly effective contraception with
low user-dependency. The only acceptable method is an intrauterine device (IUD),
provided that the subject has tolerated its use for at least 3 months before the first
dose of study drug and undertakes not to have it removed for 1 month after the last
dose of study drug. Use of hormonal contraception (by any route, including
intrauterine hormone releasing systems) or hormone replacement therapy is NOT
acceptable.
Exclusion Criteria:
- Have multiple drug allergies, or be allergic to any of the components of mifepristone
or rifampin
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any
chronic inflammatory condition)
- Have a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or
endometrial carcinoma
- Breastfeeding
- In the 1 year before first study drug administration, have a history of drug or
alcohol abuse
- In the 6 calendar months before first study drug administration, on average
- Have smoked more than 5 cigarettes/day
- Have consumed more than 21 units of alcohol/week for male subjects or 14 units
for female subjects (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or
1.5 ounces of hard liquor)
- In the 2 calendar months before first study drug administration, have donated/lost
blood or plasma in excess of 400 mL
- In the 30 days before first study drug administration, have participated in another
clinical trial of a new chemical entity or a prescription medicine
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