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

Phase 1

Completed

• Conditions: Mild and Moderate Hepatic Impairment
• Interventions: Drug: MT-7117

• Registration Number: NCT04116476
• Lead Sponsor: Mitsubishi Tanabe Pharma America Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Hepatic Impairment	MT-7117	-
Normal Healthy Matches	MT-7117	-
Moderate Hepatic Impairment	MT-7117	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117	0-96 Hours
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Miami Clinical Pharmacology Unit; 🇺🇸 Miami, Florida, United States