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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Centre for Human Drug Research
Leiden, CL, 2333 Netherlands
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02349607
Pfizer
Completed
Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints

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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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05089771 300mg
    PF-05089771 300 mg
  • Drug: PF-05089771 300 mg + pregabalin 300 mg
    PF-05089771 300 mg + pregabalin 300 mg
  • Drug: Placebo
    Placeco
  • Drug: pregabalin 300 mg
    pregabalin 300 mg
  • Drug: ibuprofen 600 mg
    ibuprofen 600 mg
  • Experimental: PF-05089771 300 mg
    Intervention: Drug: PF-05089771 300mg
  • Experimental: PF-05089771 300 mg + pregabalin 300 mg
    Intervention: Drug: PF-05089771 300 mg + pregabalin 300 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: pregabalin 300 mg
    Intervention: Drug: pregabalin 300 mg
  • Active Comparator: ibuprofen 600 mg
    Intervention: Drug: ibuprofen 600 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT02349607
B3291010
2014-004468-39 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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