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.
Age range
18 Years – 60 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum observed plasma concentration (Cmax) of dazucorilant
Timeframe: 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
Timeframe: 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
Timeframe: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8