Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT07229560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants
Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: