Itraconazole + Dazucorilant for Drug Interaction Study

Overseen By Corcept Therapeutics

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Corcept Therapeutics

Must not be taking: CYP3A4/5 inducers

Disqualifiers: Gastrointestinal, Cardiovascular, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 days

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph Custodio, PhD

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

Healthy adults who pass medical exams, have no dietary restrictions, agree to COVID-19 policies, and follow study rules can join. Women must be non-nursing or postmenopausal; men with partners must use birth control. Participants need normal kidney function and a BMI of 18.0-30.0 kg/m2.

Inclusion Criteria

I am willing to follow COVID-19 safety guidelines.

I have no dietary restrictions.

I am willing and able to follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single oral dose of dazucorilant on Days 1 and 8, and daily doses of itraconazole from Days 5-11

12 days

Continuous stay at CPC

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Dazucorilant
• Itraconazole

Trial Overview The trial tests how itraconazole affects the body's handling and safety of dazucorilant when taken by healthy adults. Participants will stay at a center for the study duration, taking both drugs orally after meals and undergoing regular blood and safety checks.

Participant Groups

Group I: Dazucorilant (300 mg) and itraconazole (200 mg) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD