Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Adults
- Interventions
- Drug: Placebo matching CORT113176
- Registration Number
- NCT04994743
- Lead Sponsor
- Corcept Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Placebo matching CORT113176 Placebo matching CORT113176 Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. Cohort 2: Placebo matching CORT113176 Placebo matching CORT113176 Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. Cohort 3: Placebo matching CORT113176 Placebo matching CORT113176 Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. Cohort 1: CORT113176 150 mg CORT113176 Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 2: CORT113176 300 mg CORT113176 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. Cohort 3: CORT113176 ≥300 mg CORT113176 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.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Adverse Events Up to Day 28
- Secondary Outcome Measures
Name Time Method Cerebrospinal Fluid Concentration of CORT113176 Approximately 3 and 5 hours after dosing on Day 7 Maximum Plasma Concentration (Cmax) of 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 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 Serum Concentration of Cortisol Before and approximately 12 hours after dosing on Days 1, 7, and 14
Trial Locations
- Locations (1)
Site 01
🇳🇱Groningen, Netherlands