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

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ClinicalTrials.gov Identifier: NCT01262690
Recruitment Status : Terminated (The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.)
First Posted : December 17, 2010
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 23, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date October 12, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Incidence and severity of adverse events. [ Time Frame: 35 days ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: 35 days ]
  • Mean change from baseline in vital signs. [ Time Frame: 35 days ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. [ Time Frame: 35 days ]
  • Incidence and severity of findings during the neurological examination. [ Time Frame: 35 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Plasma concentrations [ Time Frame: 14 days ]
  • Anti-drug antibodies [ Time Frame: 35 days ]
  • Appetite and food consumption [ Time Frame: 13 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
Official Title  ICMJE A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cachexia
Intervention  ICMJE
  • 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 Name: TAM-153
  • Drug: PF-05230901
    Single dose SC
    Other Name: TAM-163
Study Arms  ICMJE Experimental: Dose
6 treated, 3 placebos
Interventions:
  • Drug: PF-05230901
  • Drug: PF-05230901
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2011)
44
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)
70
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262690
Other Study ID Numbers  ICMJE B2291001
TAM-163 FIH Study; 3279K1-1000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP