Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug

NCT ID: NCT00644839

Last Updated: 2009-08-13

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-07-31

Brief Summary

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Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598, therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach. This study will compare the time course of drug concentrations in the body, safety, and tolerability of CP-945,598 given with and without omeprazole.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-945,598

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Administration of CP-945,598 alone in period 1

CP-945,598

Intervention Type DRUG

Adminstration of CP-945,598 with omeprazole in period 2

Interventions

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CP-945,598

Administration of CP-945,598 alone in period 1

Intervention Type DRUG

CP-945,598

Adminstration of CP-945,598 with omeprazole in period 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Body Mass Index (BMI) of 26.6 to 40.5 kg/m2.

Exclusion Criteria

* Non-prescribed use of drugs or abuse of recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure measurements falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits; medically important health conditions; recent use of prescription or non-prescription medications.
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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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

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A5351042

Identifier Type: -

Identifier Source: org_study_id

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