A Study to Evaluate the Pharmacokinetics of the CORT125134 Phase 2 Formulation in Healthy Male Subjects

NCT06094712 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT125134-122
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Maximum concentration of plasma CORT125134 (Cmax)

  Predose and at serial time points up to 120 hours after dosing

• Time of maximum concentration of plasma CORT125134 (Tmax)

  Predose and at serial time points up to 120 hours after dosing

• Area under the concentration-time curve from time zero to the time of last measurable concentration of plasma CORT125134 (AUC0-last)

  Predose and at serial time points up to 120 hours after dosing

• Area under the concentration-time curve from time zero extrapolated to infinity of plasma CORT125134 (AUC0-inf)

  Predose and at serial time points up to 120 hours after dosing

• Apparent terminal half-life of plasma CORT125134 (T1/2)

  Predose and at serial time points up to 120 hours after dosing

Study Arms (1)

CORT125134

EXPERIMENTAL

After an overnight fast, subjects will receive a single CORT125134 150-mg oral dose of the Phase 2 capsule formulation on Day 1.

Drug: CORT125134

Interventions

CORT125134 DRUG

CORT125134 150-mg capsule

CORT125134

Eligibility Criteria

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

You may qualify if:

• Body mass index between 18 kg/m\^2 to 30 kg/m\^2, inclusive, and body weight of ≥50 kg (110 pounds)
• Able to understand the study procedures, voluntarily consent to participate in this study, and provide written informed consent prior to start of any study-specific procedures
• Willing and able to remain in the study unit for the duration of the confinement period
• Must agree to use an adequate method of contraception as described in the protocol
• Must agree to study restrictions as defined in the protocol.

You may not qualify if:

• Subject and/or any of his immediate family members are employed by the study clinic, Corcept, or any subcontractor involved in this study
• Has a pregnant partner
• Has previously been enrolled in this study
• History of, and/or has been treated for, alcoholism, substance abuse, or drug abuse within the year prior to Day 1
• Positive screen for drugs of abuse or a positive alcohol result
• Current smokers and those who have smoked and/or used tobacco and/or nicotine containing products within the 6 months before Day 1 and are unable to refrain from using tobacco during the study treatment and evaluation period
• Clinically significant abnormality, in the Investigator's opinion, as indicated by the results of hematology, biochemistry, or urinalysis tests or from medical history, social history, vital signs, or physical examination
• Positive serology result for hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCV Ab) or HIV
• Current or past history of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, gastrointestinal or neurological disease
• Active renal and/or hepatic disease
• Any form of cancer within the 2 years prior to study entry, with the exception of basal cell and/or squamous cell cancer of the skin that has been resected completely and is without evidence of local recurrence or metastasis
• History and/or symptoms of adrenal insufficiency
• History of jaundice and/or subject has had a cholecystectomy
• Active acute or chronic infectious diseases
• History of clinically significant gastrointestinal disease including gastroesophageal reflux disease, malabsorption syndrome, colon cancer, chronic colitis, Crohn's disease, inflammatory bowel disease, gastroparesis, constipation, chronic diarrhea, obstruction, gastrointestinal bleeding, and/or ulcers

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Interventions

relacorilant

Study Officials

• Hazel Hunt

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: April 7, 2016
• Primary Completion: April 27, 2016
• Study Completion: April 27, 2016
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)