Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT07192692
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect Study of HSK47388 in Healthy Subjects
Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetics of HSK47388 Tablets in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2025-08
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 1, open-label, randomized, three-period crossover trial study to evaluate the effect of food and dosing and meal timing intervals on the pharmacokinetics (PK) of HSK46575 in healthy adult participants ,with an exploratory assessment of excretion pathways and excretion rates. Safety and tolerability will also be evaluated.
Detailed Description:
The study consists of 3 treatment sequences in a 3-period, crossover design. Approximately 15 healthy adult participants will be randomized 1:1:1 to one of the following sequences:
Sequence A: Participants will receive HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3）.
Sequence B: Participants will receive administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3），HSK47388 orally in the fasted state (condition 1).
Sequence C: Participants will receive HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3),HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2) .
All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood, urine and fecal samples will be collected at defined intervals for the analysis of HSK47388 and its metabolites.
Each participant's total study duration will be approximately 37 days, including screening, treatment, and follow-up.
Sequence A: Participants will receive HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3）.
Sequence B: Participants will receive administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3），HSK47388 orally in the fasted state (condition 1).
Sequence C: Participants will receive HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3),HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2) .
All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood, urine and fecal samples will be collected at defined intervals for the analysis of HSK47388 and its metabolites.
Each participant's total study duration will be approximately 37 days, including screening, treatment, and follow-up.
Study Oversight
Has Oversight DMC:
False
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?: