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

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT02711462
Collaborator
(none)
10
Enrollment
1
Location
11
Arms
6
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Cohort 1

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

Drug: PF-06687234
PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
Other Names:
  • Dekavil

    • 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.
    Other: Cohort 2

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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: 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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: Cohort 4

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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: Cohort 5

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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: Cohort 6

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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: Cohort 7

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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: 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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: 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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: 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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.
    Other: 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

    Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Names:
  • Dekavil

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [4 weeks in the single dose portion and 8 weeks in the multiple dose portion]

      To determine the safety and tolerability of PF 06687234 by assessing averse events, vital signs measurements, 12 lead ECGs, physical examination findings, blood and urine safety tests including ferritin, transferrin, serum iron, reticulocytes, hemoglobin, platelets and any abnormal laboratory results.

    Secondary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (IV and SC single doses) [Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.]

    2. Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (SC multiple doses) [Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.]

    3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (IV and SC single doses) [Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.]

    4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (SC multiple doses) [Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.]

    5. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (IV and SC single doses) [Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.]

      AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

    6. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (SC multiple doses) [Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.]

      AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

    7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (IV and SC single doses) [Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.]

      Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    8. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF 06687234 (SC multiple doses) [Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.]

      Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast

    9. Plasma Decay Half-Life (t1/2) of PF 06687234 (IV and SC single doses) [Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.]

      Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    10. Plasma Decay Half-Life (t1/2) of PF 06687234 (SC multiple doses) [Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.]

      Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    11. Incidence of development of anti-drug antibody (ADA) [up to 2 months]

    12. Incidence of development of neutralizing antibody (NAb) [up to 2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Clinical Research Unit Brussels Belgium B-1070

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer
    • Principal Investigator: Laure Mendes da Costa, Pfizer Clinical Research Unit

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02711462
    Other Study ID Numbers:
    • B7581001
    • 2015-000710-22
    • DEKAVIL
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Nov 6, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by Pfizer
    Healthy Subjects

    Study Results

    No Results Posted as of Nov 6, 2016