Status:
COMPLETED
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
Lead Sponsor:
Tanabe Pharma America, Inc.
Conditions:
Mild and Moderate Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04116476
Start Date
August 1 2019
End Date
February 16 2021
Last Update
May 15 2023
Active Locations (1)
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1
University of Miami Clinical Pharmacology Unit
Miami, Florida, United States, 33136