Clinical trial NCT06094790: A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects
Official title: An Open-Label, Repeat-Dose Study to Evaluate the Pharmacokinetics of Orally Administered CORT125134 Using the Current Capsule Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134 for 14 days.

Detailed description: Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort 2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be evaluated to select dose levels for Cohort 3 and optional Cohort 4.

The secondary objective of the study is to characterize the plasma PK profile of CORT125134 metabolites in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134.

Eligibility criteria: Inclusion Criteria:

* Give written informed consent
* Be healthy males or non-pregnant, non-lactating healthy females
* Must agree to use an adequate method of contraception as described in the study protocol
* Have a body mass index (BMI) of 18 to 32 kg/m\^2, inclusive and body weight more than 50 kg (110 pounds)
* Be willing to comply with study restrictions as described in study protocol
* Be able to comply with the requirements of the entire study
* Be judged to be in good health, based on the results of medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings
* Have suitable veins for multiple venipuncture/cannulation

Exclusion Criteria:

* Be an employee or immediate family member of the Clinical Research Unit or Corcept
* Have been previously enrolled in this study
* Have multiple drug allergies, or be allergic to any of the components of study drug
* Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
* In the 1 year before study drug administration, have a history of drug or alcohol abuse
* In the 6 calendar months before study drug administration, on average: have smoked more than 5 cigarettes/day, consumed more than 14 units (female) or 21 units (male) of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor), consumed licorice or other glycyrrhetic acid derivatives regularly, in the judgement of the Investigator
* In the 2 calendar months before study drug administration, have donated/ lost blood or plasma in excess of 400 mL
* In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
* Have a positive test for alcohol or drugs of abuse at Screening or admission
* Have a positive test for exogenous glucocorticoids at Screening
* Have clinically-relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at Screening and/or before first dose
* Have any medical or social reasons for not participating in the study raised by their primary care physician
* Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
* Have taken any prohibited prior medication, as described in study protocol

Primary outcomes:
measure: Area under the concentration-time curve over a dose-interval of plasma CORT125134 (AUCtau)
timeFrame: Predose and at serial timepoints over a dose-interval following dosing on Days 1, 7, and 14
measure: Maximum concentration of plasma CORT125134 (Cmax)
timeFrame: Predose and at serial timepoints up to 24 hours following Day 1 and Day 7 dosing, and at serial timepoints up to 120 hours following Day 14 dosing
measure: AUC from the time of dosing until 24 hours later of plasma CORT125134 (AUC0-24h)
timeFrame: Predose and at serial timepoints up to 24 hours following dosing on Days 1, 7, and 14.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences, Miami, Inc.
state: Florida
Study officials:
affiliation: Corcept Therapeutics
name: Andreas Moraitis
role: STUDY_DIRECTOR
References: