A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-06273588

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408355

B4381001

Details and patient eligibility

About

To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.

Enrollment: 5 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 measurements, 12-lead ECG and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

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 time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

50 microgram PF-06273588 intravenous

Experimental group

Description:

Subjects will receive a single intravenous microdose of PF-06273588 in period one

Treatment:

Drug: PF-06273588

Drug: PF-06273588

50 microgram PF-06273588 oral

Experimental group

Description:

Subjects will receive a single oral microdose of PF-06273588 in period two

Treatment:

Drug: PF-06273588

Drug: PF-06273588