A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
NCT01140672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2011-06-08
Summary
The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.
Conditions
- Healthy
Interventions
- DRUG
-
PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
- DRUG
-
PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
- DRUG
-
PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
- DRUG
-
PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
- DRUG
-
PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
- DRUG
-
PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2010-10-31
- Completion
- 2010-10-31
Countries
- United States
Study Locations
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