A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Investigational center
City Name, Germany
Investigational center
City Name, Hungary
Investigational center
City Name, Poland
Safety and Tolerability as measured by vital signs and Adverse Events
Number of participants with potentially clinically important vital sign measurements or tolerability issues
Time frame: 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
Time frame: Up to Day 49
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Time frame: Up to Day 49
Plasma concentration of MT-8554
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 49
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Capsule