Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants

NCT ID: NCT04994743

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2021-09-30

Brief Summary

This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1 to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176 will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments will include the measurement of serum cortisol.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: CORT113176 150 mg

Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days.

Group Type: EXPERIMENTAL

CORT113176

Intervention Type: DRUG

CORT113176 lipid capsule formulation for oral administration

Cohort 1: Placebo matching CORT113176

Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo matching CORT113176

Intervention Type: DRUG

Placebo matching CORT113176 lipid capsule formulation for oral administration

Cohort 2: CORT113176 300 mg

Participants will receive CORT113176 300 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Progression from Cohort 1 to 2 will be done based on safety and tolerability outcome from Cohort 1 and only after Cohort 1 has received study drug for ≥7 days.

Group Type: EXPERIMENTAL

CORT113176

Intervention Type: DRUG

CORT113176 lipid capsule formulation for oral administration

Cohort 2: Placebo matching CORT113176

Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo matching CORT113176

Intervention Type: DRUG

Placebo matching CORT113176 lipid capsule formulation for oral administration

Cohort 3: CORT113176 ≥300 mg

Participants will receive CORT113176 ≥300 mg not to exceed 450 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 3 is optional, and progression from Cohort 2 to 3 be done based on safety and tolerability outcome from Cohort 2 and only after Cohort 2 has received study drug for ≥7 days.

Group Type: EXPERIMENTAL

CORT113176

Intervention Type: DRUG

CORT113176 lipid capsule formulation for oral administration

Cohort 3: Placebo matching CORT113176

Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo matching CORT113176

Intervention Type: DRUG

Placebo matching CORT113176 lipid capsule formulation for oral administration

Interventions

CORT113176

CORT113176 lipid capsule formulation for oral administration

Intervention Type: DRUG

Placebo matching CORT113176

Placebo matching CORT113176 lipid capsule formulation for oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive
• Body weight ≤100 kg.
• Must agree to adhere to the requirements on contraception, exposure to sexual partners, and sperm donation as defined in the protocol
• Additional criteria apply.

Exclusion Criteria

• Received any investigational drug in a clinical research study within the last 90 days
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within past 5 years.
• Regular alcohol consumption
• Positive drug, nicotine (cotinine), or alcohol screen
• Current smokers, user of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
• Have a pregnant partner
• Clinically significant abnormal clinical chemistry, hematology (including coagulation), or urinalysis
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) results
• Positive nasopharyngeal polymerase chain reaction (PCR) test for severe acute respiratory syndrome Covid Virus-2 (SARS-CoV-2) on Day -1 or within 8 weeks prior to screening.
• Contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose
• Active renal and/or hepatic disease
• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological, or psychiatric disorder
• Abnormalities in brain and lumbar spine, or other medical or surgical conditions or clinically significant abnormal findings, for which lumbar puncture is contraindicated
• History of clinically significant back pain, back pathology and/or back injury
• History of significant active bleeding or coagulation disorder or have taken non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar puncture
• Allergy to lidocaine (Xylocaine®) or its derivatives
• Any form of cancer within the 5 years (exceptions apply)
• History and/or symptoms of adrenal insufficiency
• Have a condition that could be aggravated by glucocorticoid antagonism
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
• Additional criteria apply.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hazel Hunt, Ph.D.

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

Site 01

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2021-002456-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CORT113176-653

Identifier Type: -

Identifier Source: org_study_id