NCT01112670

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Nov 2009

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 8, 2013

Completed
Last Updated

January 24, 2013

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

April 26, 2010

Results QC Date

October 7, 2012

Last Update Submit

January 22, 2013

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Other Outcomes (5)

  • Relative Change in 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

  • Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose

  • Relative Change in Sitagliptin Renal Clearance (CLr)

    0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours

  • +2 more other outcomes

Study Arms (3)

ABCB1 Group 1

EXPERIMENTAL

ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Drug: SitagliptinDrug: atorvastatin

ABCB1 Group 2

EXPERIMENTAL

ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Drug: SitagliptinDrug: atorvastatin

ABCB1 Group 3

EXPERIMENTAL

ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses

Drug: SitagliptinDrug: atorvastatin

Interventions

SitagliptinDRUG

sitagliptin 100 mg x 1 dose

Also known as: Januvia
ABCB1 Group 1ABCB1 Group 2ABCB1 Group 3
atorvastatinDRUG

atorvastatin 40 mg x 5 doses

Also known as: Lipitor
ABCB1 Group 1ABCB1 Group 2ABCB1 Group 3

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Sitagliptin PhosphateAtorvastatin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyrrolesHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

Findings are only applicable to individuals with ABCB1 CGC/CGC, CGC/TTT, or TTT/TTT diplotypes.

Results Point of Contact

Title
Christina Aquilante, Pharm.D.
Organization
University of Colorado
christina.aquilante@ucdenver.edu
303-724-6126

Study Officials

  • Christina L Aquilante, PharmD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

November 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 24, 2013

Results First Posted

January 8, 2013

Record last verified: 2012-10

Locations

US(1)