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Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects

NCT ID: NCT01757756

Last Updated: 2012-12-31

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-11-30

Brief Summary

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This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.

Detailed Description

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Conditions

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm Label Pf-05175157, placebo, midazolam

Group Type EXPERIMENTAL

Pf-05175157

Intervention Type DRUG

200-mg administered twice daily for 14 days

placebo

Intervention Type DRUG

placebo administered twice daily for 14 days

midazolam

Intervention Type DRUG

midazolam 3-mg admistered as single doses on Day 0 and Day 11.

Interventions

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Pf-05175157

200-mg administered twice daily for 14 days

Intervention Type DRUG

placebo

placebo administered twice daily for 14 days

Intervention Type DRUG

midazolam

midazolam 3-mg admistered as single doses on Day 0 and Day 11.

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, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731017&StudyName=Multiple%20Dose%20Safety%20Toelrability%2C%20Pharmacokinetics%20and%20Midazolam%20Interaction%20In%20Healthy%20Overweight%20And%20Obese%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1731017

Identifier Type: -

Identifier Source: org_study_id