A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PF-04629991
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy non-smoking men and women
- •body mass index 18-30 kg/m2
Exclusion Criteria
- •Women must not be able to have children
- •no current infections
Arms & Interventions
first of three dosing cohorts
Intervention: PF-04629991
second of three dosing cohorts
Intervention: PF-04629991
third of three dosing cohorts
Intervention: PF-04629991
Outcomes
Primary Outcomes
Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
Time Frame: 2 weeks
Safety/Tolerability e.g., reported adverse events and safety laboratory studies
Time Frame: 2 weeks
Pharmacodynamics e.g., changes in a peripheral blood biomarker
Time Frame: 2 weeks