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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01469468

Enrollment

Registered

2011-11-10

Start date

2011-11-30

Completion date

2011-12-31

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief 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.

Interventions

DRUGSimvastatin

Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)

DRUGPF-05175157

Days 2-9 inclusive: daily dosing of PF-05175157 200 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026