Overview

Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

Status:
Completed

Trial end date:
2018-08-08

Target enrollment:
0

Participant gender:
All

Summary

A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

- Male subjects and female subjects aged ≥18 years

- Subjects who have a history of pain at least 6 months and ≤7 years attributed to
diabetic peripheral neuropathy

- A body mass index ranging from 18 to 45 kg/m2

Exclusion Criteria:

- Subjects who have participated in a clinical study of any IMP (other than placebo)
within 12 weeks (from last administration) prior to screening or who are currently
participation in another clinical study

- Unstable or uncontrolled diabetes

- Clinically significant 12-lead ECG abnormalities