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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05089771 300 mg + pregabalin 300 mg; Drug: Placebo; Drug: PF-05089771 300mg; Drug: ibuprofen 600 mg; Drug: pregabalin 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02349607

2014-004468-39 (EudraCT Number)

B3291010

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 5 patient groups, including a placebo group

PF-05089771 300 mg

Experimental group

Treatment:

Drug: PF-05089771 300mg

PF-05089771 300 mg + pregabalin 300 mg

Experimental group

Treatment:

Drug: PF-05089771 300 mg + pregabalin 300 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

pregabalin 300 mg

Active Comparator group

Treatment:

Drug: pregabalin 300 mg

ibuprofen 600 mg

Active Comparator group

Treatment:

Drug: ibuprofen 600 mg