The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Sitagliptin; Drug: atorvastatin

• Registration Number: NCT01112670
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-10
• Results First Submitted: 2012-10-07
• Results First Submitted QC: 2012-12-04
• Results First Posted: 2013-01-08
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABCB1 Group 2	Sitagliptin	ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
ABCB1 Group 1	Sitagliptin	ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
ABCB1 Group 2	atorvastatin	ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
ABCB1 Group 3	Sitagliptin	ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
ABCB1 Group 1	atorvastatin	ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
ABCB1 Group 3	atorvastatin	ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Primary Outcome Measures

Name	Time	Method
Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose
Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States