Clinical trial NCT04116476: Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild and Moderate Hepatic Impairment
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of MT-7117
timeFrame: 0-96 Hours
measure: Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117
timeFrame: 0-96 Hours
measure: Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117
timeFrame: 0-96 Hours
Secondary outcomes:
measure: Time to reach maximum plasma concentration (tmax) of MT-7117
timeFrame: 0-96 Hours
measure: Plasma terminal elimination half-life (t1/2) of MT-7117
timeFrame: 0-96 Hours
measure: Apparent oral clearance (CL/F) of MT-7117
timeFrame: 0-96 Hours
measure: Apparent volume of distribution (Vz/F) of MT-7117
timeFrame: 0-96 Hours
measure: fraction of unbound drug in plasma or serum (fu) of MT-7117
timeFrame: 0-96 Hours
measure: Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 0-96 Hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Clinical Pharmacology Unit
state: Florida
Study officials:
affiliation: Mitsubishi Tanabe Pharma America Inc.
name: Head of Medical Science
role: STUDY_DIRECTOR
References: