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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349607
• Other study ID #: B3291010
• Secondary ID: 2014-004468-39
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2015
• Last updated: April 22, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-05089771 300mg
PF-05089771 300 mg
• PF-05089771 300 mg + pregabalin 300 mg
PF-05089771 300 mg + pregabalin 300 mg
• Placebo
Placeco
• pregabalin 300 mg
pregabalin 300 mg
• ibuprofen 600 mg
ibuprofen 600 mg

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden	CL

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal pain detection threshold		1-10 hours	No
Primary	Ultra-violet light sensitized pain detection threshold		1-10 hours	No
Primary	Pressure pain tolerance threshold		1-10 hours	No
Primary	Electrical pain tolerance threshold		1-10 hours	No
Primary	Cold pressor tolerance threshold		1-10 hours	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		0.5-10	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0.5-10	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0.5-10	No
Secondary	Electrical pain detection threshold		0.5-10 hours	No
Secondary	Electrical pain area under the visual analogue scale pain curve		0.5-10 hours	No
Secondary	Electrical pain post test visual analogue scale		0.5-10 hours	No
Secondary	Electrical pain post-cold pressor pain detection threshold		0.5-10 hours	No
Secondary	Electrical pain post cold pressor pain tolerance threshold		0.5-10 hours	No
Secondary	Electrical pain post cold pressor area under the visual analogue scale curve		0.5-10 hours	No
Secondary	Electrical pain post cold pressor post test visual analogue scale		0.5-10 hours	No
Secondary	Conditioned pain modulation response pain detection threshold		0.5-10 hours	No
Secondary	Conditioned pain modulation pain tolerance threshold		0.5-10 hours	No
Secondary	Conditioned pain modulation area under the visual analogue scale curve		0.5-10 hours	No
Secondary	Condition pain modulation post test VAS		0.5-10 hours	No
Secondary	Pressure pain detection threshold		0.5-10 hours	No
Secondary	Pressure pain area under the visual analogue scale curve		0.5-10 hours	No
Secondary	Pressure pain post test visual analogue scale		0.5-10 hours	No
Secondary	Cold pressor pain detection threshold		0.5-10 hours	No
Secondary	Cold pressor area under the visual analogue scale curve		0.5-10 hours	No
Secondary	Cold pressor post test visual analogue scale		0.5-10 hours	No
Secondary	PF-05089771 half life		0.5-10 hours	No
Secondary	Pregabalin half life		0.5-10 hours	No