Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Moderate Hepatic Impairment
|
Drug: MT-7117
Single Dose of MT-7117
|
| Experimental: Normal Healthy Matches
|
Drug: MT-7117
Single Dose of MT-7117
|
| Experimental: Mild Hepatic Impairment
|
Drug: MT-7117
Single Dose of MT-7117
|
Outcome Measures
Primary Outcome Measures
- 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]
- Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117 [0-96 Hours]
Secondary Outcome Measures
- 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]
- 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]
- Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs) [0-96 Hours]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami Clinical Pharmacology Unit | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Development America, Inc.
Investigators
- Study Director: Head of Clinical Development,, Mitsubishi Tanabe Pharma Development America, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MT-7117-A02