Clinical trial · Interventional
Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants
An Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Subjects
NCT05347979CI-TRIAL-00063806completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to determine the effect of relacorilant on the pharmacokinetics (PK) of the sensitive P-glycoprotein (P-gp) substrate dabigatran etexilate.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cushing Syndrome | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabigatran Etexilate | Drug | — | UNRESOLVED |
| Relacorilant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dabigatran Etexilate (NIMP) and Relacorilant (IMP)
- description
- 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.
- interventionNames
- Drug: Dabigatran Etexilate
- Drug: Relacorilant
Primary outcomes (3)
- measure
- Maximum Observed Plasma Concentration (Cmax) of Dabigatran When Administered With and Without Relacorilant
- timeFrame
- Up to Day 14
- measure
- Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Dabigatran When Administered With and Without Relacorilant
- timeFrame
- Up to Day 14
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Must agree to use an adequate method of contraception * Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential * Body mass index (BMI) of 19.0 to 32.0 kg/m\^2 as measured at screening * Weight ≥50 kg at screening Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. * Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria * History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, bleeding disorder or abnormal bleeding, or clinically significant active bleeding, congenital or acquired clotting disorders, neurological or psychiatric disorder * History of esophagitis, gastritis, gastroesophageal reflux surgery, or significant trauma or surgery within 1 month of IMP/NIMP administration * Have poor venous access that limits phlebotomy * Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection * Clinically significant abnormal clinical chemistry, hematology or thrombocytopenia, coagulation or urinalysis * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results * Evidence of renal impairment at screening * Pregnant or lactating women * Women of childbearing potential. A woman is considered of childbearing potential unless she is permanently sterile or is postmenopausal * Participants who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. * Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP/NIMP administration. * Participants who are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months before IMP/NIMP administration, or 3 months for inhaled products * Participants who are taking, or have taken, heparin, vitamin K antagonists or anti-platelet agents within 1 month before IMP/NIMP administration * Participants who are taking, or have taken, selective serotonin re-uptake inhibitors, serotonin and norepinephrine re-uptake inhibitors within 3 months before IMP/NIMP administration * History of any drug or alcohol abuse in the past 2 years * A confirmed positive alcohol urine test at screening or admission * Current smokers and those who have smoked within the last 12 months * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months * Positive drugs of abuse test result * Male participants with pregnant or lactating partners * Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication
References
Publications (0)
Data not yet available
No reference posted for this study.