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Completed

NCT Number: NCT01098877

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04634817 Placebo

Drug

Oral solution, placebo, single dose

PF-04634817

Drug

Oral solution, 1mg, single dose

Primary outcomes

  1. Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests

    Time frame: 0-3 days

  2. Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2

    Time frame: 0-4 days

  3. Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr

    Time frame: 0-2 days

  4. p-ERK inhibition in human monocytes

    Time frame: 0-3 days

  5. Change in circulating monocytes

    Time frame: 0-3 days

Secondary outcomes

  1. Change from baseline in plasma MCP-1

    Time frame: 0-3 days

  2. MIP 1B stimulated CCR5 receptor internalization

    Time frame: 0-3 days

  3. MCP-1 stimulated CCR5 receptor internalization

    Time frame: 0-3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2010
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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