Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints

A Double Blind, Double Dummy, Randomized, Placebo-controlled, 5 Period Cross-over Study To Examine The Effect Of Pf-05089771 Alone And In Combination With Pregabalin On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls

This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-05089771 300mg; Drug: PF-05089771 300 mg + pregabalin 300 mg; Drug: Placebo; Drug: pregabalin 300 mg; Drug: ibuprofen 600 mg

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • CL
    • Leiden, CL, Netherlands, 2333
      • Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placeco
Experimental: PF-05089771 300 mg	Drug: PF-05089771 300mg; PF-05089771 300 mg
Experimental: PF-05089771 300 mg + pregabalin 300 mg	Drug: PF-05089771 300 mg + pregabalin 300 mg; PF-05089771 300 mg + pregabalin 300 mg
Active Comparator: pregabalin 300 mg	Drug: pregabalin 300 mg; pregabalin 300 mg
Active Comparator: ibuprofen 600 mg	Drug: ibuprofen 600 mg; ibuprofen 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Thermal pain detection threshold	1-10 hours
Ultra-violet light sensitized pain detection threshold	1-10 hours
Pressure pain tolerance threshold	1-10 hours
Electrical pain tolerance threshold	1-10 hours
Cold pressor tolerance threshold	1-10 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	0.5-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0.5-10
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0.5-10
Electrical pain detection threshold	0.5-10 hours
Electrical pain area under the visual analogue scale pain curve	0.5-10 hours
Electrical pain post test visual analogue scale	0.5-10 hours
Electrical pain post-cold pressor pain detection threshold	0.5-10 hours
Electrical pain post cold pressor pain tolerance threshold	0.5-10 hours
Electrical pain post cold pressor area under the visual analogue scale curve	0.5-10 hours
Electrical pain post cold pressor post test visual analogue scale	0.5-10 hours
Conditioned pain modulation response pain detection threshold	0.5-10 hours
Conditioned pain modulation pain tolerance threshold	0.5-10 hours
Conditioned pain modulation area under the visual analogue scale curve	0.5-10 hours
Condition pain modulation post test VAS	0.5-10 hours
Pressure pain detection threshold	0.5-10 hours
Pressure pain area under the visual analogue scale curve	0.5-10 hours
Pressure pain post test visual analogue scale	0.5-10 hours
Cold pressor pain detection threshold	0.5-10 hours
Cold pressor area under the visual analogue scale curve	0.5-10 hours
Cold pressor post test visual analogue scale	0.5-10 hours
PF-05089771 half life	0.5-10 hours
Pregabalin half life	0.5-10 hours

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin; Ibuprofen
• Other Study ID Numbers: B3291010; 2014-004468-39 (EudraCT Number)