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

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

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

Study Overview

• Status: Completed
• Conditions: Mild and Moderate Hepatic Impairment
• Intervention / Treatment: Drug: MT-7117

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Hepatic Impairment	Drug: MT-7117; Single Dose of MT-7117
Experimental: Normal Healthy Matches	Drug: MT-7117; Single Dose of MT-7117
Experimental: Mild Hepatic Impairment	Drug: MT-7117; Single Dose of MT-7117

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma America Inc.
• Investigators: Study Director: Head of Medical Science, Mitsubishi Tanabe Pharma America Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MT-7117-A02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No