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A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 male and/or female subjects between the ages of 18 and 55 years

- Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110
lbs).

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at screening.

NCT01146327
Pfizer
Completed
A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

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Descriptive Information
Brief Title  ICMJE A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
Official Title  ICMJE A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects
Brief SummaryPF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04620110
    Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.
  • Drug: PF-04620110
    Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.
  • Drug: PF-04620110
    Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.
  • Drug: PF-04620110
    Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.
  • Drug: Placebo
    Multiple oral doses of placebo will be given once daily for 2 weeks.
Study Arms  ICMJE
  • Experimental: PF-04620110
    Interventions:
    • Drug: PF-04620110
    • Drug: PF-04620110
    • Drug: PF-04620110
    • Drug: PF-04620110
  • Placebo Comparator: Placebo Comparator
    Intervention: Drug: Placebo
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 Completed
Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
48
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion DateJanuary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
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 Belgium,   Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146327
Other Study ID Numbers  ICMJE B0961010
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

ICMJE     Data element required by the

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

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1-800-718-1021

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