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

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 1

Conditions

Mild and Moderate Hepatic Impairment

Treatments

Drug: MT-7117

Study type

Interventional

Funder types

Industry

Identifiers

NCT04116476

MT-7117-A02

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.