Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01469481
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of [14C]PF-04991532 in healthy adult male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04991532	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: PF-04991532; a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)

Outcome Measures

Primary Outcome Measures

1. Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. [0-168 hrs]

2. Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces. [0-168 hrs]

3. radioactivity AUC [0-168 hrs]

4. plasma PF-04991532 AUC [0-168 hrs]

5. radioactivity Cmax [0-168 hrs]

6. plasma PF-04991532 Cmax [0-168 hrs]

7. plasma PF-04991532 Tmax [0-168 hrs]

8. radioactivity Tmax [0-168 hrs]

9. plasma PF-04991532 t1/2 [0-168 hrs]

10. radioactivity t1/2 [0-168 hrs]

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 measurement, 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).

• An informed consent document signed and dated by the subject.

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) or clinical findings at Screening.

• History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).

• Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Tacoma	Washington	United States	98418

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: NCT01469481
• Other Study ID Numbers: B2611007
• First Posted: Nov 10, 2011
• Last Update Posted: Jan 31, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Pfizer: diabetes mellitus; ADME
• Additional relevant MeSH terms: 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid

Study Results

No Results Posted as of Jan 31, 2012