Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants

NCT05347979 | Completed Phase 1

• 1 other identifier: CORT125134-132
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cushing Syndrome; Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

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.

Drug: Dabigatran Etexilate; Drug: Relacorilant

Interventions

Dabigatran Etexilate DRUG

Dabigatran will be administered orally as a 75 mg capsule on Day 1 and Day 12.

Also known as: Pradaxa®

Dabigatran Etexilate (NIMP) and Relacorilant (IMP)

Relacorilant DRUG

Relacorilant will be administered orally as 4 X 100 mg capsules (400 mg) on Days 3 through 13.

Dabigatran Etexilate (NIMP) and Relacorilant (IMP)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Cushing Syndrome; Neoplasms

Interventions

Dabigatran; relacorilant

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 27, 2022
• Study Start: May 25, 2022
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)