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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01408355
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-06273588; Drug: PF-06273588	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50 microgram PF-06273588 intravenous Subjects will receive a single intravenous microdose of PF-06273588 in period one	Drug: PF-06273588; Intravenous, 50 microgram, single dose
Experimental: 50 microgram PF-06273588 oral Subjects will receive a single oral microdose of PF-06273588 in period two	Drug: PF-06273588; Oral solution, 50 microgram, single dose

Outcome Measures

Primary Outcome Measures

1. The number of participants with Adverse Events as a measure of Safety and tolerability. [3 days]

2. Pharmacokinetics : peak plasma concentration [3 days]

3. Pharmacokinetics : time of peak plasma concentration [3 days]

4. Pharmacokinetics : area under plasma concentration-time curve [3 days]

5. Pharmacokinetics : Terminal plasma half life [3 days]

6. Pharmacokinetics : Plasma Clearance [3 days]

7. Pharmacokinetics : plasma volume of distribution [3 days]

8. Pharmacokinetics : oral bioavailability [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ruddington Fields	Nottingham	United Kingdom	NG11 6JS

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01408355
• Other Study ID Numbers: B4381001
• First Posted: Aug 3, 2011
• Last Update Posted: Sep 9, 2011
• Last Verified: Sep 1, 2011

Study Results

No Results Posted as of Sep 9, 2011