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

An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01165736

Enrollment

Registered

2010-07-20

Start date

2010-07-31

Completion date

2010-08-31

Last updated

2010-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics, safety, tolerability, Chronic Pain

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.

Interventions

DRUGPF-05186462

single intravenous infusion of 100 microgram

DRUGPF-05089771

single intravenous infusion of 100 microgram of PF-05089771

DRUGPF-05150122

single intravenous administration of 100 microgram PF-05150122

DRUGPF-05241328

single intravenous infusion of 100 microgram PF-05241328

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)	up to 3 days post dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026