A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects

An Open-Label, Repeat-Dose Study to Evaluate the Pharmacokinetics of Orally Administered CORT125134 Using the Current Capsule Formulation in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CORT125134 150 mg; Drug: CORT125134 250 mg; Drug: CORT125134 dose to be determined

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences, Miami, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Subjects will receive CORT125134 150 mg once daily for 14 days	Drug: CORT125134 150 mg; CORT125134 150 mg (3 X 50 mg current capsule formulation)
Experimental: Cohort 2; Subjects will receive CORT125134 250 mg once daily for 14 days	Drug: CORT125134 250 mg; CORT125134 250 mg (5 X 50 mg current capsule formulation)
Experimental: Cohort 3; Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1 and 2	Drug: CORT125134 dose to be determined; CORT125134 current capsule formulation, dose to be determined
Experimental: Cohort 4 (optional); Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1, 2, and 3, if it is considered that this cohort would aid achievement of the study objectives	Drug: CORT125134 dose to be determined; CORT125134 current capsule formulation, dose to be determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve over a dose-interval of plasma CORT125134 (AUCtau)		Predose and at serial timepoints over a dose-interval following dosing on Days 1, 7, and 14
Maximum concentration of plasma CORT125134 (Cmax)		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
AUC from the time of dosing until 24 hours later of plasma CORT125134 (AUC0-24h)	Statistical analysis of these data will be used to estimate the highest oral dose of CORT125134 current capsule formulation steady state AUC0-24h of plasma CORT125134.	Predose and at serial timepoints up to 24 hours following dosing on Days 1, 7, and 14.

Collaborators and Investigators

• Sponsor: Corcept Therapeutics
• Investigators: Study Director: Andreas Moraitis, Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Cortisone
• Other Study ID Numbers: CORT125134-453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No