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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01098877

Enrollment

Registered

2010-04-05

Start date

2010-04-30

Completion date

2010-09-30

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase1, pharmacokinetics, safety, toleration, pharmacodynamics

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.

Interventions

DRUGPF-04634817 Placebo

Oral solution, placebo, single dose

DRUGPF-04634817

Oral solution, 1mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests	0-3 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
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2	0-4 days

Secondary

Measure	Time frame
MIP 1B stimulated CCR5 receptor internalization	0-3 days
MCP-1 stimulated CCR5 receptor internalization	0-3 days
Change from baseline in plasma MCP-1	0-3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026