The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: atorvastatin; Drug: Sitagliptin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01112670

R03DK084089 (U.S. NIH Grant/Contract)

09-0531

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

33 participants in 3 patient groups

ABCB1 Group 1

Experimental group

Description:

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

Treatment:

Drug: Sitagliptin

Drug: atorvastatin

ABCB1 Group 2

Experimental group

Description:

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

Treatment:

Drug: Sitagliptin

Drug: atorvastatin

ABCB1 Group 3

Experimental group

Description:

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

Treatment:

Drug: Sitagliptin

Drug: atorvastatin