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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12.
Relacorilant will be administered orally as 4 X 100 mg capsules (400 mg) on Days 3 through 13.
Site 01
Miami, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Dabigatran When Administered With and Without Relacorilant
Time frame: 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
Time frame: 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
Time frame: Up to Day 14
Plasma Concentrations of Relacorilant
Time frame: Up to Day 6
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 30 days post final dose
Number of Participants with Clinically Significant Abnormalities in Blood Pressure and Heart Rate
Time frame: Up to Day 14
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Measurements
Time frame: Up to Day 14
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests (Clinical Chemistry, Hematology, Urinalysis)
Time frame: Up to Day 14
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