Obesity
Conditions
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.
Interventions
DRUGCP-945,598
Administration of CP-945,598 alone in period 1
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed