A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Phase 1Multiple DoseSafetyTolerationPharmacokinetic
Interventions
DRUG

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."

DRUG

placebo

given orally twice daily for 14 days

DRUG

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."

DRUG

placebo

given orally twice daily for 14 days

DRUG

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."

DRUG

placebo

given orally twice daily for 14 days

DRUG

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."

DRUG

placebo

given orally, once on Days 1 \& 14, and twice daily on Days 3-13.

Trial Locations (1)

1070

Pfizer Investigational Site, Brussels

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY