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

Mitsubishi Tanabe Pharma America Inc.1 site in 1 country23 target enrollmentAugust 1, 2019

ConditionsMild and Moderate Hepatic Impairment

InterventionsMT-7117

DrugsMT-7117

Overview

Phase: Phase 1
Intervention: MT-7117
Conditions: Mild and Moderate Hepatic Impairment
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Enrollment: 23
Locations: 1
Primary Endpoint: Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 1, 2019

End Date

February 16, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mitsubishi Tanabe Pharma America Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Moderate Hepatic Impairment

Intervention: MT-7117

Normal Healthy Matches

Intervention: MT-7117

Mild Hepatic Impairment

Intervention: MT-7117

Outcomes

Primary Outcomes

Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117

Time Frame: 0-96 Hours

Maximum observed plasma concentration (Cmax) of MT-7117

Time Frame: 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

Time Frame: 0-96 Hours

Secondary Outcomes

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)
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)
Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)(0-96 Hours)