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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00644839
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : August 13, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: CP-945,598 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CP-945,598 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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. ECGs on the first and last day of the study [ Time Frame: 2 days ]
  2. Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study [ Time Frame: 2 days ]
  3. Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study [ Time Frame: 2 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644839

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00644839     History of Changes
Other Study ID Numbers: A5351042
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: July 2008

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action