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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644839
First received: March 21, 2008
Last updated: August 11, 2009
Last verified: July 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00644839     History of Changes
Other Study ID Numbers: A5351042
Study First Received: March 21, 2008
Last Updated: August 11, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014