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NOT YET RECRUITING
NCT06558656
PHASE1

Effect of Food of NTQ5082 in Healthy Subjects

Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-08

Completion Date

2025-02

Last Updated

2024-08-19

Healthy Volunteers

Yes

Interventions

DRUG

NTQ5082 capsule

Part 1:The subjects are orally administered NT5082 capsules on an empty stomach in the first cycle and after a meal in the second cycle. Part 2:The subjects are orally administered NT5082 capsules after a meal in the first cycle and on an empty stomach in the second cycle.

Locations (1)

The Third hospital of Changsha

Changsha, Hunan, China