Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function

Study Overview
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Brief Summary
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An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function

Official Title
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An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects With Normal and Impaired Hepatic Function

Conditions
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Mild and Moderate Hepatic Impairment

Intervention / Treatment
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* Drug: MT-7117


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 18 to 75 years of age inclusive BMI 18 -35 kg/m2 If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control. Exclusion Criteria: Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches) Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin. Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer. Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment. Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (< 1 g/day for normal hepatic subjects, and < 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Hepatic Impairment<br> | Drug: MT-7117<br>* Single Dose of MT-7117<br>|
| Experimental: Normal Healthy Matches<br> | Drug: MT-7117<br>* Single Dose of MT-7117<br>|
| Experimental: Mild Hepatic Impairment<br> | Drug: MT-7117<br>* Single Dose of MT-7117<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of MT-7117 |  | 0-96 Hours | 
| Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117 |  | 0-96 Hours | 
| Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117 |  | 0-96 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach maximum plasma concentration (tmax) of MT-7117 |  | 0-96 Hours | 
| Plasma terminal elimination half-life (t1/2) of MT-7117 |  | 0-96 Hours | 
| Apparent oral clearance (CL/F) of MT-7117 |  | 0-96 Hours | 
| Apparent volume of distribution (Vz/F) of MT-7117 |  | 0-96 Hours | 
| fraction of unbound drug in plasma or serum (fu) of MT-7117 |  | 0-96 Hours | 
| Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs) |  | 0-96 Hours |