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

Mild and Moderate Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116476
• Other study ID #: MT-7117-A02
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: May 2023
• Source: Mitsubishi Tanabe Pharma America Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mild and Moderate Hepatic Impairment

Intervention

Drug:
• MT-7117
Single Dose of MT-7117

Locations

Country	Name	City	State
United States	University of Miami Clinical Pharmacology Unit	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of MT-7117		0-96 Hours
Primary	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
Primary	Area under the plasma concentration time curve from time zero to infinity (AUC0-8) of MT-7117		0-96 Hours
Secondary	Time to reach maximum plasma concentration (tmax) of MT-7117		0-96 Hours
Secondary	Plasma terminal elimination half-life (t1/2) of MT-7117		0-96 Hours
Secondary	Apparent oral clearance (CL/F) of MT-7117		0-96 Hours
Secondary	Apparent volume of distribution (Vz/F) of MT-7117		0-96 Hours
Secondary	fraction of unbound drug in plasma or serum (fu) of MT-7117		0-96 Hours
Secondary	Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)		0-96 Hours