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The primary objective is to determine the effect of relacorilant on the pharmacokinetics (PK) of the sensitive P-glycoprotein (P-gp) substrate dabigatran etexilate.
The investigational medicinal product (IMP), relacorilant, and the non-investigational medicinal product (NIMP), dabigatran etexilate, will be used to evaluate the effect of relacorilant on the PK of the sensitive P-gp substrate, dabigatran etexilate in healthy participants. Participants will receive a single dose of dabigatran etexilate before and after administration of daily (QD) doses of relacorilant for 11 days. As all participants will receive the same treatments, the study will be open-label and no randomization is required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran Etexilate (NIMP) and Relacorilant (IMP) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran Etexilate | Drug | Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Dabigatran When Administered With and Without Relacorilant | Up to Day 14 | |
| Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Dabigatran When Administered With and Without Relacorilant | Up to Day 14 | |
| Area Under the Curve from Time 0 Extrapolated to Infinity (AUC 0-inf) of Dabigatran When Administered With and Without Relacorilant | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Relacorilant | Up to Day 6 | |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 days post final dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Custodio, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Miami | Florida | 33126 | United States |
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| Relacorilant | Drug | Relacorilant will be administered orally as 4 X 100 mg capsules (400 mg) on Days 3 through 13. |
|
| Number of Participants with Clinically Significant Abnormalities in Blood Pressure and Heart Rate |
| Up to Day 14 |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Measurements | Up to Day 14 |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests (Clinical Chemistry, Hematology, Urinalysis) | Up to Day 14 |
| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C000633444 | relacorilant |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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