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OpenTrials
Completed

NCT Number: NCT04116476

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami Clinical Pharmacology Unit

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-7117

Drug

Single Dose of MT-7117

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of MT-7117

    Time frame: 0-96 Hours

  2. Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117

    Time frame: 0-96 Hours

  3. Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117

    Time frame: 0-96 Hours

Secondary outcomes

  1. Time to reach maximum plasma concentration (tmax) of MT-7117

    Time frame: 0-96 Hours

  2. Plasma terminal elimination half-life (t1/2) of MT-7117

    Time frame: 0-96 Hours

  3. Apparent oral clearance (CL/F) of MT-7117

    Time frame: 0-96 Hours

  4. Apparent volume of distribution (Vz/F) of MT-7117

    Time frame: 0-96 Hours

  5. fraction of unbound drug in plasma or serum (fu) of MT-7117

    Time frame: 0-96 Hours

  6. Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 0-96 Hours

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 4, 2019
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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