Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants

NCT06495944 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT113176-655
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults. Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12. Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of dazucorilant

  Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8

• Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) of plasma dazucorilant

  Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8

• Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of plasma dazucorilant

  Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8

Secondary Outcomes (5)

• Number of Participants with 1 or More Adverse Events

  Up to Day 18

• Number of Participants with 1 or More Clinically Significant Abnormal ECG Result

  Up to Day 18

• Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs

  Up to Day 18

• Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding

  Up to Day 18

• Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result

  Up to Day 18

Study Arms (1)

Dazucorilant (300 mg) and itraconazole (200 mg)

EXPERIMENTAL

On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, in a fed state. On Days 5-11, all participants will be administered once daily, oral doses of itraconazole 200 mg, in a fed state.

Drug: Dazucorilant; Drug: Itraconazole

Interventions

Dazucorilant DRUG

75 mg soft gelatin capsules formulation for oral administration

Also known as: CORT113176

Dazucorilant (300 mg) and itraconazole (200 mg)

Itraconazole DRUG

100 mg capsules for oral administration

Dazucorilant (300 mg) and itraconazole (200 mg)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be capable of and willing to comply with study restrictions and procedures
• Female participants must be non-nursing, have a negative pregnancy test result at screening and Day -1, and be surgically sterile for at least 90 days prior to screening or postmenopausal
• Male participants with female partners of child bearing potential must agree to use 2 acceptable forms of birth control for the duration of the study and for 90 days following the last administration of the drug; all male participants must refrain from donating sperm for this same period
• Be considered healthy by the Investigator, based on participant's reported medical history, full physical examination, clinical laboratory tests, 12-lead electrocardiograms (ECG) and vital signs
• Have normal renal function as determined by Investigator
• Have a body mass index (BMI) of 18.0 to 30.0 kg/m\^2 inclusive and body weight \>50.0 kg at screening
• Have no relevant dietary restrictions
• Be willing to comply with COVID-19 policy

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, psychiatric, neurologic, immunologic or lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
• Known or suspected malignancy
• History of pancreatitis or gall stones
• History of unexplained syncope, symptomatic hypotension, or hypoglycemia
• Personal or family history of long QTc syndrome; QTcF \>450 ms
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance
• Gastrointestinal, liver, kidney disease, or other diseases known to interfere with drug absorption, distribution, metabolism, or excretion within 3 months prior to the screening and during the screening period
• Hypersensitivity to dazucorilant or itraconazole or any components of either formulation
• Poor venous access
• Positive blood screen for infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Donated or lost ≥500 mL of blood in the previous 60 days
• Plasma donation within 30 days prior to the 1st dose of study medication
• Taken an investigational drug or participated in a clinical trial within 90 days (or 5 half-lives), whichever is longer, prior to the 1st dose of study medication
• Used prescription or over-the-counter (OTC) medication (other than ≤1 g/day acetaminophen), antacids, vitamins or herbal remedies or supplements, within 2 weeks or 5 half-lives before first study drug administration, whichever is longer
• Used food or drugs that are inducers of CYP3A4/5 and/or P-glycoprotein inducers within 30 days prior to the first dose of study medication

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Site 01

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

CORT113176; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: May 31, 2024
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)