A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03654764 In Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-03654764
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Arms & Interventions
Cohort 1
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: PF-03654764
Cohort 1
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: placebo
Cohort 2
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: PF-03654764
Cohort 2
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: placebo
Cohort 3
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: PF-03654764
Cohort 3
Subjects will be assigned to receive either PF-03654764 or placebo.
Intervention: placebo
Outcomes
Primary Outcomes
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.
Time Frame: 10 days
Secondary Outcomes
- Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, AUCtau (Day 10)/AUCtau (Day 1), CL/F(10 days)
- Urine pharmacokinetics: Ae24 & Ae24% (for once daily doses) or Ae12 & Ae12% (for twice daily dose) on Day 10, CLR(10 days)