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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644839

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: CP-945,598	Phase I

MedlinePlus related topics: Obesity

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase 1, Open-Label, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Omeprazole On The Single Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ECGs on the first and last day of the study [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	April 2008
Study Completion Date:	July 2008

Arms	Assigned Interventions
CP-945,598: Experimental	Drug: CP-945,598 Administration of CP-945,598 alone in period 1 Drug: CP-945,598 Adminstration of CP-945,598 with omeprazole in period 2

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644839

Locations

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351042
Study First Received:	March 21, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00644839
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Omeprazole

Nutrition Disorders
Overnutrition
Overweight
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009