Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 obesity
Started Apr 2008
Shorter than P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedAugust 13, 2009
July 1, 2008
3 months
March 21, 2008
August 11, 2009
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (3)
ECGs on the first and last day of the study
2 days
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
Study Arms (1)
CP-945,598
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy
- Body Mass Index (BMI) of 26.6 to 40.5 kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Miami, Florida, 33169, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 27, 2008
Study Start
April 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
August 13, 2009
Record last verified: 2008-07