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Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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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Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
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
This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus (T2DM)
  • 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
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: 100 mg PF-05231023
    Intervention: Drug: 100 mg PF-05231023
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01923389
B2901009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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