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Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
Orlando, Florida, 32803 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus (T2DM)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male and female subjects of non-childbearing potential between the ages of 21 and 70.

- Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

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

- Recent (6 months) unstable concurrent disease.

- History of allergic disease or drug allergies.

- Any condition affecting food consumption or absorption.

NCT01923389
Pfizer
Terminated
Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

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Descriptive Information
Brief Title  ICMJE Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
Official Title  ICMJE A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects
Brief SummaryThis is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus (T2DM)
Intervention  ICMJE
  • Other: Placebo
    0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.
  • Drug: 100 mg PF-05231023
    100 mg IV infusion twice a week for 4 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: 100 mg PF-05231023
    Intervention: Drug: 100 mg PF-05231023
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: January 2, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2013)
20
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion DateDecember 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects of non-childbearing potential between the ages of 21 and 70.
  • Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight >110 lbs.

Exclusion Criteria:

  • Recent (6 months) unstable concurrent disease.
  • History of allergic disease or drug allergies.
  • Any condition affecting food consumption or absorption.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01923389
Other Study ID Numbers  ICMJE B2901009
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 DateSeptember 2014

ICMJE     Data element required by the

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

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