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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05186462; Drug: PF-05089771; Drug: PF-05150122; Drug: PF-05241328

• Registration Number: NCT01165736
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-20
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous: PF-05186462	PF-05186462	-
Oral: PF-05186462	PF-05186462	-
Intravenous: PF-05089771	PF-05089771	-
Intravenous: PF-05150122	PF-05150122	-
Oral: PF-05150122	PF-05150122	-
Intravenous: PF-05241328	PF-05241328	-
Oral: PF-05089771	PF-05089771	-
Oral: PF-05241328	PF-05241328	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Edinburgh, United Kingdom