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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00644839
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 9.4

Study Details

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; Drug: CP-945,598	Phase 1

Study Design

• Study Type: Interventional
• 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: Apr 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

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. [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. [1 day]

Secondary Outcome Measures

1. ECGs on the first and last day of the study [2 days]

2. Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study [2 days]

3. Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study [2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Miami	Florida	United States	33169

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00644839
• Other Study ID Numbers: A5351042
• First Posted: Mar 27, 2008
• Last Update Posted: Aug 13, 2009
• Last Verified: Jul 1, 2008

Study Results

No Results Posted as of Aug 13, 2009