The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01112670
First received: April 26, 2010
Last updated: January 22, 2013
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Sitagliptin
Drug: atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
    AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone

  • Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
    Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone

  • Relative Change in Sitagliptin Renal Clearance (CLr) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours ] [ Designated as safety issue: Yes ]
    CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone

  • Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Atorvastatin Maximum Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABCB1 Group 1
ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Drug: Sitagliptin
sitagliptin 100 mg x 1 dose
Other Name: Januvia
Drug: atorvastatin
atorvastatin 40 mg x 5 doses
Other Name: Lipitor
Experimental: ABCB1 Group 2
ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Drug: Sitagliptin
sitagliptin 100 mg x 1 dose
Other Name: Januvia
Drug: atorvastatin
atorvastatin 40 mg x 5 doses
Other Name: Lipitor
Experimental: ABCB1 Group 3
ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Drug: Sitagliptin
sitagliptin 100 mg x 1 dose
Other Name: Januvia
Drug: atorvastatin
atorvastatin 40 mg x 5 doses
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112670

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Christina L Aquilante, PharmD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01112670     History of Changes
Other Study ID Numbers: 09-0531, R03DK084089
Study First Received: April 26, 2010
Results First Received: October 7, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Healthy volunteers

Additional relevant MeSH terms:
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Krestin
Atorvastatin
Sitagliptin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014