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

NCT03304964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-08-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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).

Sponsors & Collaborators

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2018-06-01
Completion
2018-07-01
FDA Drug
Yes

Countries

  • Netherlands

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304964 on ClinicalTrials.gov