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

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

Official Title
-----------------
A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm

Conditions
-----------------
Painful Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Drug: MT-8554 low dose
* Drug: MT-8554 middle dose
* Drug: MT-8554 high dose
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-8554 low dose<br>Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period. | Drug: MT-8554 low dose<br>* Capsule<br>|
| Experimental: MT-8554 middle dose<br>Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period. | Drug: MT-8554 middle dose<br>* Capsule<br>|
| Experimental: MT-8554 high dose<br>Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period. | Drug: MT-8554 high dose<br>* Capsule<br>|
| Experimental: MT-8554, then placebo<br>The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase | Drug: MT-8554 low dose<br>* Capsule<br>Drug: MT-8554 middle dose<br>* Capsule<br>Drug: MT-8554 high dose<br>* Capsule<br>Drug: Placebo<br>* Capsule<br>|
| Experimental: Placebo, then MT-8554<br>The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase | Drug: MT-8554 low dose<br>* Capsule<br>Drug: MT-8554 middle dose<br>* Capsule<br>Drug: MT-8554 high dose<br>* Capsule<br>Drug: Placebo<br>* Capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as measured by vital signs and Adverse Events | Number of participants with potentially clinically important vital sign measurements or tolerability issues | Up to Day 22 | 
| Efficacy as measured by reduction in pain using a numerical rating scale. | Pain reduction using an 11-point numerical rating scale | Up to Day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with electrocardiogram (ECG) findings of potential clinical importance | Number of participants with potentially clinically important ECG findings | Up to Day 49 | 
| Plasma concentration of MT-8554 | Maximum Observed Plasma Concentration (Cmax) | Up to Day 49 |