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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-06273588

• Registration Number: NCT01408355
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-30
• Study Start: 2011-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-03
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
50 microgram PF-06273588 intravenous	PF-06273588	Subjects will receive a single intravenous microdose of PF-06273588 in period one
50 microgram PF-06273588 oral	PF-06273588	Subjects will receive a single oral microdose of PF-06273588 in period two

Primary Outcome Measures

Name	Time	Method
The number of participants with Adverse Events as a measure of Safety and tolerability.	3 days
Pharmacokinetics : peak plasma concentration	3 days
Pharmacokinetics : time of peak plasma concentration	3 days
Pharmacokinetics : area under plasma concentration-time curve	3 days
Pharmacokinetics : Terminal plasma half life	3 days
Pharmacokinetics : Plasma Clearance	3 days
Pharmacokinetics : plasma volume of distribution	3 days
Pharmacokinetics : oral bioavailability	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Ruddington Fields, Nottingham, United Kingdom