First In Human Study Of Increasing Oral Doses Of PF-04634817
A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
1 other identifier
interventional
27
1 country
1
Brief Summary
The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 13, 2010
October 1, 2010
5 months
March 26, 2010
October 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
0-3 days
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2
0-4 days
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr
0-2 days
p-ERK inhibition in human monocytes
0-3 days
Change in circulating monocytes
0-3 days
Secondary Outcomes (3)
Change from baseline in plasma MCP-1
0-3 days
MIP 1B stimulated CCR5 receptor internalization
0-3 days
MCP-1 stimulated CCR5 receptor internalization
0-3 days
Study Arms (11)
Placebo
PLACEBO COMPARATORCohort 1, 1mg
EXPERIMENTALCohort 1, 3mg
EXPERIMENTALCohort 1, 10mg
EXPERIMENTALCohort 2, 30mg
EXPERIMENTALCohort 2, 100mg
EXPERIMENTALCohort 2, 300mg
EXPERIMENTALCohort 3, 600mg
EXPERIMENTALCohort 3, 900mg
EXPERIMENTALCohort 3, up to 900mg (fed)
EXPERIMENTALCohort 3, placebo (fed)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
- Body mass index of 17.5 to 30.5 kg/m2 and total body weight \> 50kg.
You may not qualify if:
- Evidence or history of any clinically significant disease.
- Treatment with an investigational drug within 30 days of study start
- Use of prescription and non-prescription medicines within 7 days of study start
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2010
First Posted
April 5, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 13, 2010
Record last verified: 2010-10