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A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT01262690
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
10
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose

6 treated, 3 placebos

Drug: PF-05230901
Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.
Other Names:
  • TAM-153

    • Drug: PF-05230901
    Single dose SC
    Other Names:
  • TAM-163

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of adverse events. [35 days]

    2. Incidence and severity of clinical laboratory abnormalities. [35 days]

    3. Mean change from baseline in vital signs. [35 days]

    4. Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. [35 days]

    5. Incidence and severity of findings during the neurological examination. [35 days]

    Secondary Outcome Measures

    1. Plasma concentrations [14 days]

    2. Anti-drug antibodies [35 days]

    3. Appetite and food consumption [13 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy subjects
    Exclusion Criteria:

    • History of seizures, including childhood seizures.

    • History of movement disorders or related neurological conditions.

    • History of head trauma associated with loss of consciousness.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01262690
    Other Study ID Numbers:
    • B2291001
    • TAM-163 FIH Study; 3279K1-1000
    First Posted:
    Dec 17, 2010
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Pfizer
    First-in-human (FIH)
    Single Ascending Dose (SAD) Study
    TAM-163
    PF-05230901
    Cachexia
    Additional relevant MeSH terms:
    Wasting Syndrome
    Cachexia

    Study Results

    No Results Posted as of Oct 12, 2011