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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05241328; Drug: PF-05089771; Drug: PF-05186462; Drug: PF-05150122

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165736

B3071001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 8 patient groups

Intravenous: PF-05186462

Active Comparator group

Treatment:

Drug: PF-05186462

Drug: PF-05186462

Oral: PF-05186462

Active Comparator group

Treatment:

Drug: PF-05186462

Drug: PF-05186462

Intravenous: PF-05089771

Active Comparator group

Treatment:

Drug: PF-05089771

Drug: PF-05089771

Oral: PF-05089771

Active Comparator group

Treatment:

Drug: PF-05089771

Drug: PF-05089771

Intravenous: PF-05150122

Active Comparator group

Treatment:

Drug: PF-05150122

Drug: PF-05150122

Oral: PF-05150122

Active Comparator group

Treatment:

Drug: PF-05150122

Drug: PF-05150122

Intravenous: PF-05241328

Active Comparator group

Treatment:

Drug: PF-05241328

Drug: PF-05241328

Oral: PF-05241328

Active Comparator group

Treatment:

Drug: PF-05241328

Drug: PF-05241328