The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

University of Colorado, Denver33 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SitagliptinDRUG

sitagliptin 100 mg x 1 dose

atorvastatinDRUG

atorvastatin 40 mg x 5 doses

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity