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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
75 mg soft gelatin capsules formulation for oral administration
100 mg capsules for oral administration
Site 01
Baltimore, Maryland, United States
Maximum observed plasma concentration (Cmax) of dazucorilant
Time frame: 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
Time frame: 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
Time frame: Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8
Number of Participants with 1 or More Adverse Events
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal ECG Result
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding
Time frame: Up to Day 18
Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result
Time frame: Up to Day 18
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