NCT01165736

Brief Summary

The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2010

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

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

1 month

First QC Date

July 16, 2010

Last Update Submit

August 23, 2010

Conditions

Healthy

Keywords

pharmacokineticssafetytolerabilityChronic Pain

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)

    up to 3 days post dose

  • pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve

    up to 3 days post dose

Secondary Outcomes (1)

  • safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)

    up to 3 days post dose

Study Arms (8)

Intravenous: PF-05186462

ACTIVE COMPARATOR
Drug: PF-05186462

Oral: PF-05186462

ACTIVE COMPARATOR
Drug: PF-05186462

Intravenous: PF-05089771

ACTIVE COMPARATOR
Drug: PF-05089771

Oral: PF-05089771

ACTIVE COMPARATOR
Drug: PF-05089771

Intravenous: PF-05150122

ACTIVE COMPARATOR
Drug: PF-05150122

Oral: PF-05150122

ACTIVE COMPARATOR
Drug: PF-05150122

Intravenous: PF-05241328

ACTIVE COMPARATOR
Drug: PF-05241328

Oral: PF-05241328

ACTIVE COMPARATOR
Drug: PF-05241328

Interventions

PF-05186462DRUG

single intravenous infusion of 100 microgram

Intravenous: PF-05186462
PF-05089771DRUG

single intravenous infusion of 100 microgram of PF-05089771

Intravenous: PF-05089771
PF-05150122DRUG

single intravenous administration of 100 microgram PF-05150122

Intravenous: PF-05150122
PF-05241328DRUG

single intravenous infusion of 100 microgram PF-05241328

Intravenous: PF-05241328

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 50 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 and clinical laboratory tests)
  • Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

You may not qualify if:

  • Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
  • History of febrile illness within 5 days prior to the first dose a positive urine drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Edinburgh, EH14 4AP, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Chronic Pain

Interventions

PF-05089771

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 20, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

GB(1)