Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06558656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Food of NTQ5082 in Healthy Subjects
Sponsor:
Nanjing Chia-tai Tianqing Pharmaceutical
Organization:
Study Overview
Official Title:
A Randomized, Open Label, Two Sequence, Two Period, Double Crossover-design Phase I Clinical Trial of NTQ5082 Capsules Taken by Healthy Subjects on an Empty Stomach (i.e, Fasting) as Well as After a Meal (i.e. Fed)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral administration of NTQ5082 capsules and the safety and tolerability of single oral administration of NTQ5082 capsules on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy subjects
Detailed Description:
None
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?: