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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: CP-945,598

• Registration Number: NCT00644839
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Study Start: 2008-04
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Disposition First Submitted: 2009-08-11
• Disposition First Submitted QC: 2009-08-11
• Last Update Submitted: 2009-08-11
• Disposition First Posted: 2009-08-13
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CP-945,598	CP-945,598	-

Primary Outcome Measures

Name	Time	Method
Measurement of drug concentrations in serum from blood samples collected at various times after first single dose of CP-945,598 on days 1-6, 8, 15.	1 day
Measurement of drug concentrations in serum from blood samples collected at 4 days before given omeprazole, and after second single dose of CP-945,598 on days 1-6, 8.	1 day

Secondary Outcome Measures

Name	Time	Method
Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study	2 days
Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study	2 days
ECGs on the first and last day of the study	2 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States