HealthyPhase 1NCT03304964

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

A Phase 1 study testing FP-025 (MMP-12 inhibitor) in people with Healthy, run by Foresee Pharmaceuticals Co., Ltd. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: FP-025 (MMP-12 inhibitor)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteNetherlands
Study dates: 21 Jul 2017to 1 Jul 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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/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.
A resting pulse ≥40 bpm and ≤100 bpm at screening and on Day -1.
A resting systolic blood pressure of ≤150 mmHg and a resting diastolic blood pressure of ≤95 mmHg at screening and on Day -1.
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.
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.

Show all 10Show fewer

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.
Signed Informed Consent prior to any study related procedures.
Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.

Who cannot join

Eligible subjects must meet none of the following exclusion criteria:
The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to the first dose of study product (or within 5 half-lives prior to the first dose of study product for any medication ingested, whichever is longer).
The subject has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the investigator.
The subject has taken any investigational products within 60 days prior to the first dose of study product.
The subject has a history of severe drug allergy or hypersensitivity or food allergy.
The subject has a history or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), haematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder.

Show all 21Show fewer

The subject has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of study product.
The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or non-peripheral vascular surgery within 6 months prior to the first dose of study product.
The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the study product.
The subject has had a clinically significant illness within 4 weeks prior to the first dose of study product.
The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study product.
The subject has donated blood more than 250 mL within 2 months prior to the first dose of study product.
The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
The subject is a current smoker or uses other nicotine containing products. Ex-smokers must have ceased smoking at least 6 months prior to the first dose of study product.
The subject has tested positive at screening or on Day -1 for drugs of abuse or alcohol.
A female subject who has a positive urine pregnancy test at screening or on Day -1.
The subject's corrected QT interval (QTcF) (Fridericia's correction) is >450 ms as read on the printout of the ECG produced by the ECG equipment and evaluated by the Investigator at screening and on Day -1. An out-of-range or abnormal ECG may be repeated. In total, 3 ECGs should be recorded consecutively and the Investigator must evaluate the triplicate ECG. If the subject's QTcF is >450 ms on at least 2 ECGs, the subject must be excluded.
In general, subjects should refrain from excessive physical exercise and strenuous sports activities (endurance sports) for at least 4 days before screening and Day -1.
The subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Legal incapacity or limited legal capacity at screening and on Day -1.
Employees of the Investigator or study centre, as well as first degree family members of the employees or the Investigator.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

QPS Netherlands B.V.
Petrus Campersingel 123, Provincie Groningen, 9713 AG

Other trials in Netherlands

About this study

Official title: 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

Read the 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
Being tested: FP-025 (MMP-12 inhibitor)
Keywords: FP-025, MMP-12 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03304964
Study group	Role	What they receive
100 mg FP-025 (b.i.d)	Experimental	Not described Receives: Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (b.i.d.)	Experimental	Not described Receives: Drug: FP-025 (MMP-12 inhibitor)
400 mg FP-025 (b.i.d)	Experimental	Not described Receives: Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (single dose; fasted)	Experimental	Not described Receives: Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (single dose; fed condition)	Experimental	Not described Receives: Drug: FP-025 (MMP-12 inhibitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-emergent, AEs, SAEs and ECG abnormalities up to end-of-study (EOS).
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
Measured: 17 days ± 2 days
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).
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.
Measured: 17 days ± 2 days

Secondary outcomes (26)

Analysis of the plasma concentration-time on Day 1 (Cmax)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (Tmax)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-12)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-24)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-inf)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AI)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmax)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Tmax )
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmin)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-12)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-inf)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cavg)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (FI)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (t½)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vss/F)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vz/ F)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Plasma concentration-time ratio for AUC0-12 (Day 8)/AUC0-12 (Day 1)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Plasma concentration-time ratio for ratio of AUC0-12(Day 8)/AUC0-inf (Day 1)
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for Cmax
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for Tmax
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-t
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-inf
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for Kel
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for t½
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for CL/F
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days
Analysis of the plasma concentration-time for Vz/F
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
Measured: 17 days ± 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 20171 Jul 2018

First posted9 Oct 2017
Study start21 Jul 2017
Primary completion1 Jun 2018
Study completion1 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: MAD part (Part 1) - sequential multiple ascending doses; FE part (Part 2) - crossover food effect after single dose administration
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03304964
Sponsor's protocol ID: FP02C-17-001
Status last verified: Aug 2018
First submitted: 22 Sep 2017
Last updated: 13 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.
PubMed 33331980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03304964
Acronym / sponsor ID: FP02C-17-001
Conditions: Healthy
Keywords: FP-025, MMP-12 inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Jul 2017 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jul 2018 (actual)
First posted: 9 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: MAD part (Part 1) - sequential multiple ascending doses; FE part (Part 2) - crossover food effect after single dose administration

Arm	Type	Receives
100 mg FP-025 (b.i.d)	Experimental	Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (b.i.d.)	Experimental	Drug: FP-025 (MMP-12 inhibitor)
400 mg FP-025 (b.i.d)	Experimental	Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (single dose; fasted)	Experimental	Drug: FP-025 (MMP-12 inhibitor)
200 mg FP-025 (single dose; fed condition)	Experimental	Drug: FP-025 (MMP-12 inhibitor)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.
A resting pulse ≥40 bpm and ≤100 bpm at screening and on Day -1.
A resting systolic blood pressure of ≤150 mmHg and a resting diastolic blood pressure of ≤95 mmHg at screening and on Day -1.
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.
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.

Key exclusion criteria (21 listed)

The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to the first dose of study product (or within 5 half-lives prior to the first dose of study product for any medication ingested, whichever is longer).
The subject has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the investigator.
The subject has taken any investigational products within 60 days prior to the first dose of study product.
The subject has a history of severe drug allergy or hypersensitivity or food allergy.
The subject has a history or presence of any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (in particular diabetes or pre-diabetes), haematological, dermatological, venereal, neurological, chronic infectious or psychiatric disease or other major disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	100 mg FP-025 (b.i.d)
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	200 mg FP-025 (b.i.d.)
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	400 mg FP-025 (b.i.d)
FP-025 (MMP-12 inhibitor)Treatment D: single oral dose of 200 mg FP-025 under fasted conditions.	Drug	200 mg FP-025 (single dose; fasted)
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).	Drug	200 mg FP-025 (single dose; fed condition)

Primary outcome

Treatment-emergent, AEs, SAEs and ECG abnormalities up to end-of-study (EOS).
Time frame: 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).
Time frame: 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.

26 secondary outcomes

Analysis of the plasma concentration-time on Day 1 (Cmax)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (Tmax)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-12)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-24)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-inf)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AI)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmax)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Tmax )
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmin)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-12)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-inf)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cavg)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (FI)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (t½)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vss/F)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vz/ F)
Time frame: 17 days ± 2 days
Plasma concentration-time ratio for AUC0-12 (Day 8)/AUC0-12 (Day 1)
Time frame: 17 days ± 2 days
Plasma concentration-time ratio for ratio of AUC0-12(Day 8)/AUC0-inf (Day 1)
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for Cmax
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for Tmax
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-t
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-inf
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for Kel
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for t½
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for CL/F
Time frame: 17 days ± 2 days
Analysis of the plasma concentration-time for Vz/F
Time frame: 17 days ± 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Derived from this study: PubMed 33331980Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP-025 (MMP-12 inhibitor) in people with Healthy, run by Foresee Pharmaceuticals Co., Ltd. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent, AEs, SAEs and ECG abnormalities up to end-of-study (EOS). (time frame: 17 days ± 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03304964, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.