Phase 4
Completed N=21
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology
Healthy
Source: ClinicalTrials.gov NCT01112670 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity — 3638; 3502; 3129 ng*hr/ml — p=0.83
Summary
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity |
3638; 3502; 3129 | 0.83 |
| PRIMARY Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax) |
454; 438; 394 | 0.67 |
| PRIMARY Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr) |
254; 232; 359 | 0.21 |
| SECONDARY Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity |
3501; 3430; 3117 | 0.90 |
| SECONDARY Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax) |
428; 420; 370 | 0.56 |
| SECONDARY Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr) |
280; 226; 339 | 0.22 |
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.
Data sourced from ClinicalTrials.gov (NCT01112670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.