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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |