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

A Double Blind, Placebo-Controlled, Randomized, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DS-7309	1, 2.5, 5, 10, 20 mg DS-7309 powder in bottle.
DRUG	placebo	placebo to match part 2 DS-7309

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2013-05-27
• Last updated: 2013-05-27

Locations

1 site across 1 country: United States