Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495944
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy Adult Participants
Sponsor:
Corcept Therapeutics
Organization:
Corcept Therapeutics
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None