NCT03304964

A Phase 1, Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Doses in Healthy Subjects

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the MMP-12 Inhibitor FP-025 After Multiple Oral Ascending Dose Administration, and to Evaluate the Effect of Food After a Single Oral Dose Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FP-025 (MMP-12 inhibitor)	Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.
DRUG	FP-025 (MMP-12 inhibitor)	Treatment B: 14 oral doses of 200 mg FP-025 (n=6) or placebo (n=2) in 8 days.
DRUG	FP-025 (MMP-12 inhibitor)	Treatment C: 14 oral doses of 400 mg FP-025 (n=6) or placebo (n=2) in 8 days.
DRUG	FP-025 (MMP-12 inhibitor)	Treatment D: single oral dose of 200 mg FP-025 under fasted conditions.
DRUG	FP-025 (MMP-12 inhibitor)	Treatment E: single oral dose of 200 mg FP-025 after intake of a high-fat, high-calorie breakfast (fed condition).

Timeline

• Start date: 2017-07-21
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2017-10-09
• Last updated: 2018-08-13

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study