Overview

This trial is active, not recruiting.

Conditions healthy, hepatic impairment
Treatment t-817ma
Phase phase 1
Sponsor Toyama Chemical Co., Ltd.
Collaborator Celerion
Start date February 2016
End date June 2017
Trial size 36 participants
Trial identifier NCT02693197, T817MAUS113

Summary

The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.

The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Mild hepatic impairment subjects
t-817ma
A single oral dose of 448 mg
(Experimental)
Healthy subjects matched to subjects in Cohort 1
t-817ma
A single oral dose of 448 mg
(Experimental)
Moderate hepatic impairment subjects
t-817ma
A single oral dose of 448 mg
(Experimental)
Healthy subjects matched to subjects in Cohort 3
t-817ma
A single oral dose of 448 mg
(Experimental)
Severe hepatic impairment subjects
t-817ma
A single oral dose of 448 mg
(Experimental)
Healthy subjects matched to subjects in Cohort 5
t-817ma
A single oral dose of 448 mg

Primary Outcomes

Measure
Plasma concentrations
time frame: 8 days
Area under the plasma concentration time curve (AUC)
time frame: 8 days
Maximum observed plasma concentration (Cmax)
time frame: 8 days
Time to reach the maximum observed plasma concentration (tmax)
time frame: 8 days
Apparent terminal elimination rate constant
time frame: 8 days
Apparent terminal elimination half-life (t½)
time frame: 8 days
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
time frame: 8 days
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
time frame: 8 days
Metabolite to parent ratio (MPR)
time frame: 8 days

Secondary Outcomes

Measure
Number of participants with treatment-related adverse events
time frame: 8days

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: For subjects with mild, moderate or severe hepatic impairment 1. Adult male or female, 18 - 75 years of age 2. Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2 3. Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status Exclusion Criteria: 1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI. 3. History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients. 4. Female subjects who are pregnant or lactating.

Additional Information

Official title A Phase 1, Two-Part, Open-Label, Parallel-Cohort, Single-Dose Study to Determine the Pharmacokinetics of T-817MA in Adult Subjects With Hepatic Impairment and in Healthy Adult Subjects
Principal investigator Richard Preston, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Toyama Chemical Co., Ltd..