The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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ABCB1 Group 1

ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

sitagliptin 100 mg x 1 dose

atorvastatin

Intervention Type DRUG

atorvastatin 40 mg x 5 doses

ABCB1 Group 2

ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

sitagliptin 100 mg x 1 dose

atorvastatin

Intervention Type DRUG

atorvastatin 40 mg x 5 doses

ABCB1 Group 3

ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

sitagliptin 100 mg x 1 dose

atorvastatin

Intervention Type DRUG

atorvastatin 40 mg x 5 doses

Interventions

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Sitagliptin

sitagliptin 100 mg x 1 dose

Intervention Type DRUG

atorvastatin

atorvastatin 40 mg x 5 doses

Intervention Type DRUG

Other Intervention Names

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Januvia Lipitor

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women between 21 to 60 years of age will be recruited to participate in this study.
* Subjects will be eligible if metabolic, renal, hepatic, and hematological laboratory tests are within normal limits.

Exclusion Criteria

* Subjects will be excluded from the study if they have a current or past history of cardiovascular, hepatic, endocrine (e.g., diabetes), renal, pancreatic, gastrointestinal, pulmonary, immunologic, hematologic, or neurologic disease.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes