SeaView Research
Miami, Florida, 33126, United States
NCT Number: NCT03259542
This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.
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Notify Me18 year–65 year
Male
Interventional
Phase 1
Miami, Florida, 33126, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days
itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
Time frame: Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
Time frame: Day 42 compared to Day 28
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
Time frame: Day 42 compared to Day 14
Time frame: Day 42 compared to Day 14
Time frame: Days 14 and 28
Elimination half-life (T1/2)
Time frame: Days 1 through 28
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)
Corcept Therapeutics
Industry
A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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