NCT02004678

Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus

Phase I, Single-Blind, Placebo-Controlled, Randomized, Two-Part, Sequential, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus. This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of DS-1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DS-1150b
OTHER	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2013-12-09
• Last updated: 2018-12-24

Locations

1 site across 1 country: United States