A Phase 1 interventional study of CORT125134 in Healthy, sponsored by Corcept Therapeutics. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Corcept Therapeutics · Phase 1, Interventional, and Other
A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.
Following an overnight fast, subjects will be administered a single 150-mg oral dose of CORT125134 capsules on the morning of Day 1. Blood samples for determination of PK parameters will be collected predose and at serial time points up to 120 hours after study drug administration. The secondary objective of the study is to characterize the PK profile of metabolite CORT125201 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.
Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After an overnight fast, subjects will receive a single CORT125134 150-mg oral dose of the Phase 2 capsule formulation on Day 1.
Drug: CORT125134
CORT125134 150-mg capsule
Maximum concentration of plasma CORT125134 (Cmax)
Time frame: Predose and at serial time points up to 120 hours after dosing
Time of maximum concentration of plasma CORT125134 (Tmax)
Time frame: Predose and at serial time points up to 120 hours after dosing
Area under the concentration-time curve from time zero to the time of last measurable concentration of plasma CORT125134 (AUC0-last)
Time frame: Predose and at serial time points up to 120 hours after dosing
Area under the concentration-time curve from time zero extrapolated to infinity of plasma CORT125134 (AUC0-inf)
Time frame: Predose and at serial time points up to 120 hours after dosing
Apparent terminal half-life of plasma CORT125134 (T1/2)
Time frame: Predose and at serial time points up to 120 hours after dosing
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corcept Therapeutics