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NCT number NCT03304964
Study type Interventional
Source Foresee Pharmaceuticals Co., Ltd.
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Status Active, not recruiting
Phase Phase 1
Start date July 21, 2017
Completion date November 2017

Clinical Trial Summary

This is a single-center, phase I study consisting of 2 parts. The first part is a multiple ascending dose (MAD) part with a randomized, double-blind, placebo-controlled design in 3 treatment groups of 8 subjects (6 active; 2 placebo). The second part is a food effect (FE) part with a randomized, open-label, 2-period, 2-way crossover, single dose design in 8 subjects.


Clinical Trial Description

MAD part (Part 1)

After assessing eligibility during a 4-week screening period, subjects will be randomized to 1 of the 3 treatments as follows:

- Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.

- Treatment B: 14 oral doses of 200 mg FP-025 (n=6) or placebo (n=2) in 8 days.

- Treatment C: 14 oral doses of 400 mg FP-025 (n=6) or placebo (n=2) in 8 days.

FE part (Part 2)

After assessing eligibility during a 4-week screening period, 1 treatment group of 8 subjects (8 active; 0 placebo) will be randomized to a treatment sequence (D followed by E, or E followed by D):

- Treatment D: single oral dose of 200 mg FP-025 under fasted conditions, and

- Treatment E: single oral dose of 200 mg FP-025 after intake of a high-fat, high-calorie breakfast (fed condition).

The total study planned duration for each part, Part 1 and Part 2 of the study, is approximately 6 weeks, including screening period.


Study Design


Related Conditions & MeSH terms


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