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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Drug: CP-945,598

Study type

Interventional

Funder types

Industry

Identifiers

NCT00644839
A5351042

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

CP-945,598
Experimental group
Treatment:
Drug: CP-945,598
Drug: CP-945,598

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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