Mild and Moderate Hepatic Impairment
Conditions
Brief summary
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
Interventions
DRUGMT-7117
Single Dose of MT-7117
Sponsors
Tanabe Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vz/F) of MT-7117 | 0-96 Hours |
| Time to reach maximum plasma concentration (tmax) of MT-7117 | 0-96 Hours |
| Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs) | 0-96 Hours |
| fraction of unbound drug in plasma or serum (fu) 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 |
Countries
United States
Outcome results
None listed