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Completed

NCT Number: NCT01812265

Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects

This study will evaluate the pharmacological activity of PF-06305591 in healthy male volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.

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Key information

Conditions

Healthy

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 male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Subjects unable to tolerate pre-study Cpressor testing at screening.
  • Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to 20.
  • Broken skin on hands or forearms

Treatment and study plan

PF-06305591

Drug

single Dose

Placebo

Drug

Single Dose

Primary outcomes

  1. Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval

    Time frame: 24h

    Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline in a 2 minute assessment.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 24h

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    Time frame: 24h

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Crossover Study To Investigate The Effects Of Pf-06305591 On Cold Pain In Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2013
Registry last updated
Sep 17, 2013

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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