48
Participants
Start Date
March 31, 2010
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
UK-396,082
"100mg given orally twice daily for 14 days~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
placebo
given orally twice daily for 14 days
UK-396,082
"300mg given orally twice daily for 14 days~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
placebo
given orally twice daily for 14 days
UK-396,082
"1000mg given orally twice daily for 14 days~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
placebo
given orally twice daily for 14 days
UK-396,082
"UK-396,082 given orally, once on Days 1 \& 14, and twice daily on Days 3-13.~The decision to proceed to the next higher dose will be made jointly by the Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts. Dependent on the emerging safety, tolerability and PK data, Cohort 4 may be recruited to study a higher (or lower) dose of UK-396,082 in order to characterize further the safety, toleration and PK and/or to define the maximum tolerated dose. The dose in Cohort 4 will be selected such that the predicted Cmax will not exceed 46 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
placebo
given orally, once on Days 1 \& 14, and twice daily on Days 3-13.
Pfizer Investigational Site, Brussels
Lead Sponsor
Pfizer
INDUSTRY