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

NCT ID: NCT01146327

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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PF-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 Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04620110

Group Type EXPERIMENTAL

PF-04620110

Intervention Type DRUG

Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.

PF-04620110

Intervention Type DRUG

Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.

PF-04620110

Intervention Type DRUG

Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.

PF-04620110

Intervention Type DRUG

Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple oral doses of placebo will be given once daily for 2 weeks.

Interventions

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PF-04620110

Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.

Intervention Type DRUG

PF-04620110

Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.

Intervention Type DRUG

PF-04620110

Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.

Intervention Type DRUG

PF-04620110

Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.

Intervention Type DRUG

Placebo

Multiple oral doses of placebo will be given once daily for 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Belgium Singapore

Related Links

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Other Identifiers

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B0961010

Identifier Type: -

Identifier Source: org_study_id

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