drugset / Trial / NCT00707954

Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

NCT00707954

Phase 1/2 Completed 61 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.

Timeline

Start
2008-06
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 25 mg Oral
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 100 mg Oral
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 200 mg Oral
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 400 mg Oral