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

Sponsor
Corcept Therapeutics
Study ID
NCT04994743
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • CORT113176 — DRUG
    CORT113176 lipid capsule formulation for oral administration
  • Placebo matching CORT113176 — DRUG
    Placebo matching CORT113176 lipid capsule formulation for oral administration

Study Details

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.

Key Dates

First listed
Aug 6, 2021
Start date
Jul 13, 2021
Status verified
Oct 2021
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: CORT113176 150 mg
    Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days.
  • Placebo Comparator: Cohort 1: Placebo matching CORT113176
    Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.
  • Experimental: 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.
  • Placebo Comparator: Cohort 2: Placebo matching CORT113176
    Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.
  • Experimental: 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.
  • Placebo Comparator: Cohort 3: Placebo matching CORT113176
    Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days.

Primary Outcome Measure

Number of Participants with One or More Adverse Events [ Time Frame: Up to Day 28 ]

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