drugset / Trial / NCT01862939

A Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DS-7309 in Healthy Volunteers and Subjects With Type 2 Diabetes Mellitus

NCT01862939 ↗

Phase 1 Completed 52 enrolled Daiichi Sankyo
RandomizedSingle-groupTriple-blindTreatment

Summary

This is a randomized, placebo-controlled, 2-part, sequential, single ascending dose study. Part 1 is planned as 6 sequential escalation treatment groups. Part 2 is a randomized, placebo-controlled, two-period sequential pharmacodynamic (PD) arm.

Timeline

Start
2011-04
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject DS-7309 Unknown 1 mg Oral
Subject DS-7309 Unknown 2.5 mg Oral
Subject DS-7309 Unknown 5 mg Oral
Subject DS-7309 Unknown 10 mg Oral
Subject DS-7309 Unknown 15 mg Oral
Subject DS-7309 Unknown 20 mg Oral