Healthy
Conditions
Keywords
FP-025, MMP-12 inhibitor
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.
Interventions
DRUGFP-025 (MMP-12 inhibitor)
Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.
Sponsors
Foresee Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
MAD part (Part 1) - double-blind; FE part (Part 2) - open-label
Intervention model description
MAD part (Part 1) - sequential multiple ascending doses; FE part (Part 2) - crossover food effect after single dose administration
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Eligible subjects must meet all of the following inclusion criteria: 1. Males aged ≥18 and ≤65 years or postmenopausal females aged ≥18 and ≤65 years, with a BMI ≥18 kg/m2 and ≤30 kg/m2. 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. 2. A resting pulse ≥40 bpm and ≤100 bpm at screening and on Day -1. 3. A resting systolic blood pressure of ≤150 mmHg and a resting diastolic blood pressure of ≤95 mmHg at screening and on Day -1. 4. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at screening and on Day -1. Out of normal ranges values may be accepted by the Investigator, if not clinically significant. 5. 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. 6. Male subjects must use adequate contraception, if applicable, during the study and until 3 months after completion of the study. 7. 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. 8. Signed Informed Consent prior to any study related procedures. 9. Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion criteria
Eligible subjects must meet none of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent, AEs, SAEs and ECG abnormalities up to end-of-study (EOS). | 17 days ± 2 days | Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring |
| Change from baseline for vital sign, ECG parameters [(QTc = QT/RR1/3.)], and clinical laboratory test for scheduled time point up to end-of-study (EOS). | 17 days ± 2 days | Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring. The ECG parameter QTc will be calculated according to Fridericia's correction using the ECG parameters QT interval (QT) and RR recorded. QTc (msec) = QT (msec)/RR (sec)1/3. QT msec will be calculated with RR sec to arrive at one reported value for QTc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the plasma concentration-time on Day 1 (Tmax) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 1 (AUC0-12) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 1 (AUC0-inf) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (AI) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (Cmax) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (Tmax ) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (Cmin) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (AUC0-12) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (AUC0-inf) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (Cavg) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (FI) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (t½) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 1 (AUC0-24) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 8 (Vz/ F) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Plasma concentration-time ratio for AUC0-12 (Day 8)/AUC0-12 (Day 1) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Plasma concentration-time ratio for ratio of AUC0-12(Day 8)/AUC0-inf (Day 1) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time for Cmax | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for Tmax | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for AUC0-t | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for AUC0-inf | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for Kel | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for t½ | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for CL/F | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time for Vz/F | 17 days ± 2 days | Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025. |
| Analysis of the plasma concentration-time on Day 8 (Vss/F) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
| Analysis of the plasma concentration-time on Day 1 (Cmax) | 17 days ± 2 days | Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects. |
Countries
Netherlands
Outcome results
None listed