Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589635
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
A Drug-Drug Interaction DDI Study of ADC189 With Itraconazole in Healthy Adult Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 ADC189 in healthy adults
Participants in this study will complete screening assessments within 14 days before the first dose of ADC189 Participants will be admitted to the clinical pharmacology center CPC and complete 2 periods of treatments On Day 1 and 26 each participant will receive a single oral dose of ADC189 45mg under fasting condition On Day 22 all participants will receive oral doses of itraconazole 200 mg bid after meal From Day 23 to Day 25 and Day 26-D39 participants will receive itraconazole 200 mgqd Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26 Participants will receive a telephone follow-up on D47 3 days for a final visit
Participants in this study will complete screening assessments within 14 days before the first dose of ADC189 Participants will be admitted to the clinical pharmacology center CPC and complete 2 periods of treatments On Day 1 and 26 each participant will receive a single oral dose of ADC189 45mg under fasting condition On Day 22 all participants will receive oral doses of itraconazole 200 mg bid after meal From Day 23 to Day 25 and Day 26-D39 participants will receive itraconazole 200 mgqd Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26 Participants will receive a telephone follow-up on D47 3 days for a final visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None