A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in heathy people is to investigate the safety, toleration and time
      course of PF-03654764 in the blood, following multiple doses given once or twice daily by
      mouth for 10 days.
    


Intervention name(s): PF-03654764; placebo; PF-03654764; placebo; PF-03654764; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.; orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.; 12mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.; orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.; 12mg orally twice daily on Days 1-9, and once on Day 10 After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.; oral twice daily on Days 1-9 and once on Day 10. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1 multiple dose safety toleration pharmacokinetic