First In Human Study Of Increasing Oral Doses Of PF-04634817

NCT01098877 — Phase 1, Completed, 27 participants, Pfizer

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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

Registry	NCT01098877
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	27 (Actual)
Sponsor	Pfizer (Industry)
Conditions	Healthy
Interventions	PF-04634817 Placebo, PF-04634817 (Drug)
Dates	start 2010-04-01, primary completion 2010-09-01, completion 2010-09-01, first posted 2010-04-05, last updated 2010-10-13
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions
Placebo	Placebo comparator	Drug: PF-04634817 Placebo
Cohort 1, 1mg	Experimental	Drug: PF-04634817
Cohort 1, 3mg	Experimental	Drug: PF-04634817
Cohort 1, 10mg	Experimental	Drug: PF-04634817
Cohort 2, 30mg	Experimental	Drug: PF-04634817
Cohort 2, 100mg	Experimental	Drug: PF-04634817
Cohort 2, 300mg	Experimental	Drug: PF-04634817
Cohort 3, 600mg	Experimental	Drug: PF-04634817
Cohort 3, 900mg	Experimental	Drug: PF-04634817
Cohort 3, up to 900mg (fed)	Experimental	Drug: PF-04634817
Cohort 3, placebo (fed)	Placebo comparator	Drug: PF-04634817 Placebo

PF-04634817 Placebo (Drug): Oral solution, placebo, single dose
PF-04634817 (Drug): Oral solution, 1mg, single dose
PF-04634817 (Drug): Oral solution, 3mg, single dose
PF-04634817 (Drug): Oral solution, 10mg, single dose
PF-04634817 (Drug): Oral solution, 30mg, single dose
PF-04634817 (Drug): Oral solution, 100mg, single dose
PF-04634817 (Drug): Oral solution, 300mg, single dose
PF-04634817 (Drug): Oral solution, 600mg, single dose
PF-04634817 (Drug): Oral solution, 900mg, single dose
PF-04634817 (Drug): Oral solution, up to 900mg, single dose after food
PF-04634817 Placebo (Drug): Oral solution, placebo, single dose after food

+Outcome measures

Primary outcomes

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

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]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Pfizer Investigational Site	New Haven, Connecticut	United States

+Investigators

Pfizer CT.gov Call Center, Study director, Pfizer