A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469468
• Other study ID #: B1731012
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects with normal results in all screening examinations.

• Body Mass Index of 17.5 to 35.5 kg/m2

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Known history of intolerance to simvastatin or other statins.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Simvastatin
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
• PF-05175157
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration curve of simvastatin and simvastatin acid		10 days
Primary	Maximum observed plasma concentration of simvastatin and simvastatin acid		10 days
Primary	Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed		10 days
Primary	If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time		10 days
Primary	If the data permit, terminal elimination half-life of simvastatin and simvastatin acid		10 days