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Completed

NCT Number: NCT01393652

Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy Volunteers

Exclusion criteria

Standard Healthy Volunteers

Treatment and study plan

PF-05105679

Drug

Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: 3 days

  2. Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT

    Time frame: 3 days

Secondary outcomes

  1. Average AUC2min VAS (cold pressor test) of PF-05105679.

    Time frame: 24 hours

  2. Cold detection threshold (°C) of PF-05105679.

    Time frame: 24 hours

  3. Cold pain threshold (°C) of PF-05105679.

    Time frame: 24 hours

  4. Stimulus-response function to cold stimuli following menthol application.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers

Acronym: SINGLE DOSE

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2011
Registry last updated
Oct 3, 2011

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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