PK Study of T-817 in Subjects With Hepatic Impairment

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693197
• Other study ID #: T817MAUS113
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2016
• Last updated: November 22, 2017
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Toyama Chemical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• T-817MA
A single oral dose of 448 mg

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Toyama Chemical Co., Ltd.	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations		8 days
Primary	Area under the plasma concentration time curve (AUC)		8 days
Primary	Maximum observed plasma concentration (Cmax)		8 days
Primary	Time to reach the maximum observed plasma concentration (tmax)		8 days
Primary	Apparent terminal elimination rate constant		8 days
Primary	Apparent terminal elimination half-life (t½)		8 days
Primary	Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)		8 days
Primary	Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)		8 days
Primary	Metabolite to parent ratio (MPR)		8 days
Secondary	Number of participants with treatment-related adverse events		8days