Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

Exclusion Criteria

• •Current, clinically significant medical comorbidities
• •Abnormal liver dysfunction
• •Pruritus attributed mainly to any disease unrelated to kidney disease
• •Calcium x phosphorus product \>80 mg2/dL2 or hemoglobin \<7 g/dL or parathyroid hormone levels \>1000 pg/mL at Screening
• •Received ultraviolet B treatment within 30 days prior to Screening
• •Started or changed psychotropic medication within 14 days prior to Screening
• •Is receiving opioid antagonists or opioid agonists within 7 days prior to Screening and not willing to abstain from these medications during the study.
• •Started or changed medications, creams or emollients including over-the-counter oil bath treatment for relief of pruritus within 7 days prior to Screening
• •Has known hypersensitivity to opioids or the study drug ingredients
• •Is currently participating in an investigational drug or device clinical study or was participating in such a study within 30 days prior to the start of Screening
• •Female subject who is known to be pregnant or nursing
• •Is considered not suitable for inclusion in the study in the opinion of Investigator
• •Has current suicidal ideation with some intent to act or with specific plan and intent or had suicidal behavior at any time in subject's life