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Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

NCT ID: NCT02711462

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.

Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.

A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Subjects will receive 2mg of PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 2

Subjects will receive 20mg PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 3

This is an optional cohort that may be added anytime during the study. In this cohort, subjects will receive PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 4

Subjects will receive 40mg of PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 5

Subjects will receive 80mg of PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 6

Subjects receive a single dose of PF 06687234 or placebo via the IV route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 7

This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 8

Subjects in this cohort may receive 20 mg of PF 06687234 or placebo via the SC route every week with a total of 5 doses

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 9

Subjects in this cohort may receive 40 mg of PF 06687234 or placebo via the SC route every two weeks with a total of 3 doses

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 10

This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Cohort 11

This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts

Group Type OTHER

PF-06687234

Intervention Type DRUG

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Placebo

Intervention Type DRUG

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Interventions

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PF-06687234

PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses

Intervention Type DRUG

Placebo

In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.

Intervention Type DRUG

Other Intervention Names

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Dekavil

Eligibility Criteria

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Inclusion Criteria

* Healthy females of non childbearing potential and healthy males
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Ability to personally sign and date the informed consent document and able to comply with schedule of activities
* For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.

Exclusion Criteria

* Evidence or history of clinically significant health concerns
* Treatment with an investigational drug within 30 days
* Exposure to any live vaccines within 28 days prior to investigational product administration.
* History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
* Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
* Pregnant female subjects
* History of sensitivity to heparin
* Unwilling or unable to comply with the Lifestyle Guidelines as stated in the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Laure Mendes da Costa

Role: PRINCIPAL_INVESTIGATOR

Pfizer Clinical Research Unit

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581001&StudyName=A%20Phase%201%2C%20Double%20Blind%2C%20Third-party%20Open%2C%20Randomized%2C%20Placebo%20Controlled%2C%20Single%20And%20Multiple%20Dose%2C%20Parallel%20Group%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%2C%20And%20Pharmacodynamics%20Of%20Pf-06687234%20In%20Healthy%20Subjects

To obtain contact information for a study center near you, click here.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581001&StudyName=A+Phase+1%2C+Double+Blind%2C+Third-party+Open%2C+Randomized%2C+Placebo+Controlled%2C+Single+And+Multiple+Dose%2C+Parallel+Group+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+Pharmacokinetics%2C+And+Pharmacodynamics+Of+Pf-06687234+In+Healthy+Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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2015-000710-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEKAVIL

Identifier Type: OTHER

Identifier Source: secondary_id

B7581001

Identifier Type: -

Identifier Source: org_study_id