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Completed

NCT Number: NCT01112670

The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

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

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Key information

Conditions

Healthy

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitagliptin

Drug

sitagliptin 100 mg x 1 dose

Other names: Januvia

atorvastatin

Drug

atorvastatin 40 mg x 5 doses

Other names: Lipitor

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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

    AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone

  2. 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

    Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone

  3. 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

    CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2010
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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