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Completed

NCT Number: NCT02238717

Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints

This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, CL, 2333, Netherlands

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 or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

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).
  • A positive urine drug screen.

Treatment and study plan

PF-06372865 (65mg)

Drug

single oral dose (65 mg)

PF-06372865 (15mg)

Drug

single oral dose (15mg)

Pregabalin

Drug

single oral dose (300mg)

Placebo

Drug

matching oral placebo

Primary outcomes

  1. Thermal pain detection threshold

    Time frame: 0.5 - 6 hours

  2. Ultra-violet light sensitized pain detection threshold

    Time frame: 0.5 - 6 hours

  3. Pressure pain tolerance threshold

    Time frame: 0.5 - 6 hours

  4. Electrical pain tolerance threshold

    Time frame: 0.5 - 6 hours

  5. Cold pressor tolerance threshold

    Time frame: 0.5 - 6 hours

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0.5 - 10 hours

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0.5 - 10 hours

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0.5 - 10 hours

  4. Electrical pain detection threshold

    Time frame: 0.5 - 10 hours

  5. Electrical pain area under the visual analogue scale pain curve

    Time frame: 0.5 - 10 hours

  6. Electrical pain post test visual analogue scale

    Time frame: 0.5 - 10 hours

  7. Electrical pain post-cold pressor pain detection threshold

    Time frame: 0.5 - 10 hours

  8. Electrical pain post cold pressor pain tolerance threshold

    Time frame: 0.5 - 10 hours

  9. Electrical pain post cold pressor area under the visual analogue scale curve

    Time frame: 0.5 - 10 hours

  10. Electrical pain post cold pressor post test visual analogue scale

    Time frame: 0.5 - 10 hours

  11. Conditioned pain modulation response pain detection threshold

    Time frame: 0.5 - 10 hours

  12. Conditioned pain modulation pain tolerance threshold

    Time frame: 0.5 - 10 hours

  13. Conditioned pain modulation area under the visual analogue scale curve

    Time frame: 0.5 - 10 hours

  14. Condition pain modulation post test VAS

    Time frame: 0.5 - 10 hours

  15. Pressure pain detection threshold

    Time frame: 0.5 - 10 hours

  16. Pressure pain area under the visual analogue scale curve

    Time frame: 0.5 - 10 hours

  17. Pressure pain post test visual analogue scale

    Time frame: 0.5 - 10 hours

  18. Cold pressor pain detection threshold

    Time frame: 0.5 - 10 hours

  19. Cold pressor area under the visual analogue scale curve

    Time frame: 0.5 - 10 hours

  20. Cold pressor post test visual analogue scale

    Time frame: 0.5 - 10 hours

  21. PF-06372865 half life

    Time frame: 0.5 - 10 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double Blind, Double Dummy, Randomized, Placebo-controlled, 4 Period Cross-over Study To Examine The Effect Of Pf-06372865 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin As A Positive Control

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2014
Registry last updated
Dec 16, 2014

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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