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

Foresee Pharmaceuticals Co., Ltd.1 site in 1 country32 target enrollmentJuly 21, 2017

ConditionsHealthy

InterventionsFP-025 (MMP-12 inhibitor)

DrugsFP-025 (MMP-12 inhibitor)

Overview

Phase: Phase 1
Intervention: FP-025 (MMP-12 inhibitor)
Conditions: Healthy
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Enrollment: 32
Locations: 1
Primary Endpoint: Treatment-emergent, AEs, SAEs and ECG abnormalities up to end-of-study (EOS).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 21, 2017

End Date

July 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Foresee Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eligible subjects must meet all of the following inclusion criteria:
•Males aged ≥18 and ≤65 years or postmenopausal females aged ≥18 and ≤65 years, with a BMI ≥18 kg/m2 and ≤30 kg/m
•Female subjects must be of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months amenorrhoea and follicle stimulating hormone (FSH) levels \>40 IU/L.
•A resting pulse ≥40 bpm and ≤100 bpm at screening and on Day -
•A resting systolic blood pressure of ≤150 mmHg and a resting diastolic blood pressure of ≤95 mmHg at screening and on Day -
•Baseline laboratory test values within reference ranges based on the blood and urine samples taken at screening and on Day -
•Out of normal ranges values may be accepted by the Investigator, if not clinically significant.
•The subject is, in the opinion of the Investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
•Male subjects must use adequate contraception, if applicable, during the study and until 3 months after completion of the study.
•Subjects participating in the FE part of the study must be willing and able to consume the entire high-fat, high-calorie breakfast in the designated timeframe.