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

NCT01262690

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cachexia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of seizures, including childhood seizures.


- History of movement disorders or related neurological conditions.


- History of head trauma associated with loss of consciousness.

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CachexiaA Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
NCT01262690
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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