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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-02-16

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

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Detailed Description

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Conditions

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Mild and Moderate Hepatic Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Hepatic Impairment

Group Type EXPERIMENTAL

MT-7117

Intervention Type DRUG

Single Dose of MT-7117

Normal Healthy Matches

Group Type EXPERIMENTAL

MT-7117

Intervention Type DRUG

Single Dose of MT-7117

Mild Hepatic Impairment

Group Type EXPERIMENTAL

MT-7117

Intervention Type DRUG

Single Dose of MT-7117

Interventions

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MT-7117

Single Dose of MT-7117

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes