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

NCT02238717 | Completed Phase 1

• 2 other identifiers: B74310032014-003015-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pain; evoked pain; healthy volunteer; pharmacodynamics

Outcome Measures

Primary Outcomes (5)

• Thermal pain detection threshold

  0.5 - 6 hours

• Ultra-violet light sensitized pain detection threshold

  0.5 - 6 hours

• Pressure pain tolerance threshold

  0.5 - 6 hours

• Electrical pain tolerance threshold

  0.5 - 6 hours

• Cold pressor tolerance threshold

  0.5 - 6 hours

Secondary Outcomes (21)

• Maximum Observed Plasma Concentration (Cmax)

  0.5 - 10 hours

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

  0.5 - 10 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0.5 - 10 hours

• Electrical pain detection threshold

  0.5 - 10 hours

• Electrical pain area under the visual analogue scale pain curve

  0.5 - 10 hours

Study Arms (4)

PF-06372865 (65mg)

EXPERIMENTAL

Drug: PF-06372865 (65mg)

PF-06372865 (15mg)

EXPERIMENTAL

Drug: PF-06372865 (15mg)

Pregabalin

ACTIVE COMPARATOR

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-06372865 (65mg) DRUG

single oral dose (65 mg)

PF-06372865 (65mg)

PF-06372865 (15mg) DRUG

single oral dose (15mg)

PF-06372865 (15mg)

Pregabalin DRUG

single oral dose (300mg)

Pregabalin

Placebo DRUG

matching oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, CL, 2333, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

PF-06372865; Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

NL (1)