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

August 9, 2018 updated by: Foresee Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 exclusion criteria:

  1. 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).
  2. The subject has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the investigator.
  3. The subject has taken any investigational products within 60 days prior to the first dose of study product.
  4. The subject has a history of severe drug allergy or hypersensitivity or food allergy.
  5. 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.
  6. 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.
  7. 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.
  8. The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the study product.
  9. The subject has had a clinically significant illness within 4 weeks prior to the first dose of study product.
  10. The subject has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study product.
  11. The subject has donated blood more than 250 mL within 2 months prior to the first dose of study product.
  12. The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).
  13. 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.
  14. The subject has tested positive at screening or on Day -1 for drugs of abuse or alcohol.
  15. A female subject who has a positive urine pregnancy test at screening or on Day -1.
  16. 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.
  17. 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.
  18. The subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
  19. Legal incapacity or limited legal capacity at screening and on Day -1.
  20. Employees of the Investigator or study centre, as well as first degree family members of the employees or the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 100 mg FP-025 (b.i.d)
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).
EXPERIMENTAL: 200 mg FP-025 (b.i.d.)
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).
EXPERIMENTAL: 400 mg FP-025 (b.i.d)
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).
EXPERIMENTAL: 200 mg FP-025 (single dose; fasted)
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).
EXPERIMENTAL: 200 mg FP-025 (single dose; fed condition)
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
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.
17 days ± 2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Analysis of the plasma concentration-time on Day 1 (Cmax)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (Tmax)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-12)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-24)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 1 (AUC0-inf)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AI)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmax)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Tmax )
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cmin)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-12)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (AUC0-inf)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Cavg)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (FI)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (t½)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vss/F)
Time Frame: 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.
17 days ± 2 days
Analysis of the plasma concentration-time on Day 8 (Vz/ F)
Time Frame: 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.
17 days ± 2 days
Plasma concentration-time ratio for AUC0-12 (Day 8)/AUC0-12 (Day 1)
Time Frame: 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.
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
Pharmacokinetics (PK) analysis to measure the plasma concentration of FP-025 after multiple oral ascending doses of FP-025 in healthy subjects.
17 days ± 2 days
Analysis of the plasma concentration-time for Cmax
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for Tmax
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-t
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for AUC0-inf
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for Kel
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for t½
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for CL/F
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days
Analysis of the plasma concentration-time for Vz/F
Time Frame: 17 days ± 2 days
Effect of food on the Pharmacokinetics (PK) analysis after single dose administration of FP-025.
17 days ± 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foresee Pharmaceuticals Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FP02C-17-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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