NCT06495944

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

An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Characterize the Impact of the Cytochrome P450 3A Inhibitor Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Dazucorilant	75 mg soft gelatin capsules formulation for oral administration
DRUG	Itraconazole	100 mg capsules for oral administration

Timeline

• Start date: 2024-05-31
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2024-07-11
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study