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

Last updated on November 10, 2019

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

NCT01262690
Pfizer
Terminated
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

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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 SummaryThis 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 DescriptionNot 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 DateSeptember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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