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

Healthy Volunteers Clinical Trial

Official title:

An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408355
• Other study ID #: B4381001
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2011
• Last updated: September 8, 2011
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicine and Healthcare products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-06273588
Intravenous, 50 microgram, single dose
• PF-06273588
Oral solution, 50 microgram, single dose

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Ruddington Fields	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with Adverse Events as a measure of Safety and tolerability.		3 days	Yes
Primary	Pharmacokinetics : peak plasma concentration		3 days	No
Primary	Pharmacokinetics : time of peak plasma concentration		3 days	No
Primary	Pharmacokinetics : area under plasma concentration-time curve		3 days	No
Primary	Pharmacokinetics : Terminal plasma half life		3 days	No
Primary	Pharmacokinetics : Plasma Clearance		3 days	No
Primary	Pharmacokinetics : plasma volume of distribution		3 days	No
Primary	Pharmacokinetics : oral bioavailability		3 days	No

External Links

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