NCT00747058CompletedPhase 1
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics
Study Overview
Brief Summary
The purpose of this study is to determine the safety and tolerability of PF-03864086 in healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of elimination of PF-03864086 from the body once the compound is ingested).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy male volunteers
- •no drug history
- •no other medication for 28 pre-dose
Exclusion Criteria
- •age below 21 years
- •age above 55 years
Arms & Interventions
healthy volunteers
Experimental
Intervention: PF-3864086 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics
Time Frame: measured intensively in the first 48 hours and continue out to day 14
Tolerability
Time Frame: measured intensively in the first 48 hours and continue out to day 14
Secondary Outcomes
- Temperature change(continuous recording over the first 48h post dose)
Investigators
Study Sites (1)
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