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Relacorilant for Cushing Syndrome
Phase 1
Waitlist Available
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post final dose
Awards & highlights
Study Summary
This trial is looking at how a drug called relacorilant affects the levels of another drug, dabigatran etexilate, in the body.
Eligible Conditions
- Cushing Syndrome
- Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post final dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post final dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Curve from Time 0 Extrapolated to Infinity (AUC 0-inf) of Dabigatran When Administered With and Without Relacorilant
Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Dabigatran When Administered With and Without Relacorilant
Maximum Observed Plasma Concentration (Cmax) of Dabigatran When Administered With and Without Relacorilant
Secondary outcome measures
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with Clinically Significant Abnormalities in Blood Pressure and Heart Rate
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Measurements
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dabigatran Etexilate (NIMP) and Relacorilant (IMP)Experimental Treatment2 Interventions
Following an overnight fast, participants will receive 75 mg dabigatran etexilate on Day 1, 400 mg dose of relacorilant QD on Days 3 to 13, and 75 mg dabigatran etexilate on Day 12. On Day 12, dabigatran etexilate will be dosed at approximately the same time as the relacorilant dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relacorilant
Not yet FDA approved
Dabigatran
FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,350 Total Patients Enrolled
12 Trials studying Cushing Syndrome
1,530 Patients Enrolled for Cushing Syndrome
Joseph Custodio, PhDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
150 Total Patients Enrolled
Frequently Asked Questions
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