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

NCT04994743 | Completed Phase 1

• 2 other identifiers: CORT113176-6532021-002456-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Adverse Events

  Up to Day 28

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of CORT113176

  Before dosing and a pre-specified time points up to Day 17

• Time of Cmax (Tmax) of Plasma CORT113176

  Before dosing and a pre-specified time points up to Day 17

• Apparent Elimination Half-life (t1/2) of Plasma CORT113176

  Before dosing and a pre-specified time points up to Day 17

• Area Under the Plasma Concentration-time Curve (AUC) of Plasma CORT113176

  Before dosing and a pre-specified time points up to Day 17

• Cerebrospinal Fluid Concentration of CORT113176

  Approximately 3 and 5 hours after dosing on Day 7

Study Arms (6)

Cohort 1: CORT113176 150 mg

EXPERIMENTAL

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

Drug: CORT113176

Cohort 1: Placebo matching CORT113176

PLACEBO COMPARATOR

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

Drug: Placebo matching CORT113176

Cohort 2: CORT113176 300 mg

EXPERIMENTAL

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.

Drug: CORT113176

Cohort 2: Placebo matching CORT113176

PLACEBO COMPARATOR

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

Drug: Placebo matching CORT113176

Cohort 3: CORT113176 ≥300 mg

EXPERIMENTAL

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.

Drug: CORT113176

Cohort 3: Placebo matching CORT113176

PLACEBO COMPARATOR

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

Drug: Placebo matching CORT113176

Interventions

CORT113176 DRUG

CORT113176 lipid capsule formulation for oral administration

Cohort 1: CORT113176 150 mg; Cohort 2: CORT113176 300 mg; Cohort 3: CORT113176 ≥300 mg

Placebo matching CORT113176 DRUG

Placebo matching CORT113176 lipid capsule formulation for oral administration

Cohort 1: Placebo matching CORT113176; Cohort 2: Placebo matching CORT113176; Cohort 3: Placebo matching CORT113176

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

CORT113176

Study Officials

• Hazel Hunt, Ph.D.

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: July 13, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)