First In Human Study Of Increasing Oral Doses Of PF-04634817
- Registration Number
- NCT01098877
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo PF-04634817 Placebo - Cohort 3, placebo (fed) PF-04634817 Placebo - Cohort 3, 600mg PF-04634817 - Cohort 2, 100mg PF-04634817 - Cohort 1, 3mg PF-04634817 - Cohort 1, 1mg PF-04634817 - Cohort 1, 10mg PF-04634817 - Cohort 2, 30mg PF-04634817 - Cohort 2, 300mg PF-04634817 - Cohort 3, up to 900mg (fed) PF-04634817 - Cohort 3, 900mg PF-04634817 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States