NCT02349607

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

January 23, 2015

Last Update Submit

April 22, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (22)

  • 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

  • +17 more secondary outcomes

Study Arms (5)

PF-05089771 300 mg

EXPERIMENTAL
Drug: PF-05089771 300mg

PF-05089771 300 mg + pregabalin 300 mg

EXPERIMENTAL
Drug: PF-05089771 300 mg + pregabalin 300 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

pregabalin 300 mg

ACTIVE COMPARATOR
Drug: pregabalin 300 mg

ibuprofen 600 mg

ACTIVE COMPARATOR
Drug: ibuprofen 600 mg

Interventions

PF-05089771 300mgDRUG

PF-05089771 300 mg

PF-05089771 300 mg
PF-05089771 300 mg + pregabalin 300 mgDRUG

PF-05089771 300 mg + pregabalin 300 mg

PF-05089771 300 mg + pregabalin 300 mg
PlaceboDRUG

Placeco

Placebo
pregabalin 300 mgDRUG

pregabalin 300 mg

pregabalin 300 mg
ibuprofen 600 mgDRUG

ibuprofen 600 mg

ibuprofen 600 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research

Leiden, CL, 2333, Netherlands

Location

MeSH Terms

Interventions

PF-05089771PregabalinIbuprofen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsPhenylpropionatesAcids, Carbocyclic

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

January 23, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

NL(1)