Clinical trial NCT01112670: The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Official title: The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Secondary outcomes:
measure: Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Other outcomes:
measure: Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Relative Change in Sitagliptin Renal Clearance (CLr)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours
measure: Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
measure: Atorvastatin Maximum Plasma Concentration (Cmax)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christina L Aquilante, PharmD
role: PRINCIPAL_INVESTIGATOR
References: