A Phase 1 interventional study of Mifepristone 300 MG and Itraconazole 100 MG in Drug Interaction Potentiation and Healthy, sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Other
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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.
Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 3 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 9 (28%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In the 6 calendar months before study drug administration, on average
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered.
Drug: Mifepristone 300 MG · Drug: Itraconazole 100 MG
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
Cmax of mifepristone at Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
Time frame: Day 42 compared to Day 28
AUC0-24 of mifepristone at 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 28
Cmax of mifepristone at Day 42 compared to Day 14
Time frame: Day 42 compared to Day 14
AUC0-24 of mifepristone compared to Day 14
Time frame: Day 42 compared to Day 14
T1/2 of mifepristone
Elimination half-life (T1/2)
Time frame: Days 14 and 28
Ctrough of mifepristone
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state \[taken directly before next administration\]) (Ctrough)
Time frame: Days 1 through 28
Ran from Aug 2017 to primary completion in Dec 2017, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Mifepristone · Itraconazole