Back to resultsPK Study of T-817 in Subjects With Hepatic Impairment
Primary Purpose
Healthy, Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
T-817MA
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
For subjects with mild, moderate or severe hepatic impairment
- Adult male or female, 18 - 75 years of age
- Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
- 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:
- 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.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
- Female subjects who are pregnant or lactating.
Sites / Locations
- University of Miami
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1:T-817MA
Cohort 2:T-817MA
Cohort 3:T-817MA
Cohort 4:T-817MA
Cohort 5 :T-817MA
Cohort 6:T-817MA
Arm Description
Mild hepatic impairment subjects
Healthy subjects matched to subjects in Cohort 1
Moderate hepatic impairment subjects
Healthy subjects matched to subjects in Cohort 3
Severe hepatic impairment subjects
Healthy subjects matched to subjects in Cohort 5
Outcomes
Primary Outcome Measures
Plasma concentrations
Area under the plasma concentration time curve (AUC)
Maximum observed plasma concentration (Cmax)
Time to reach the maximum observed plasma concentration (tmax)
Apparent terminal elimination rate constant
Apparent terminal elimination half-life (t½)
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
Metabolite to parent ratio (MPR)
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Full Information
NCT ID
NCT02693197
First Posted
January 26, 2016
Last Updated
November 22, 2017
Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
Collaborators
Celerion
1. Study Identification
Unique Protocol Identification Number
NCT02693197
Brief Title
PK Study of T-817 in Subjects With Hepatic Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
Collaborators
Celerion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hepatic Impairment
Keywords
Hepatic Impairment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1:T-817MA
Arm Type
Experimental
Arm Description
Mild hepatic impairment subjects
Arm Title
Cohort 2:T-817MA
Arm Type
Experimental
Arm Description
Healthy subjects matched to subjects in Cohort 1
Arm Title
Cohort 3:T-817MA
Arm Type
Experimental
Arm Description
Moderate hepatic impairment subjects
Arm Title
Cohort 4:T-817MA
Arm Type
Experimental
Arm Description
Healthy subjects matched to subjects in Cohort 3
Arm Title
Cohort 5 :T-817MA
Arm Type
Experimental
Arm Description
Severe hepatic impairment subjects
Arm Title
Cohort 6:T-817MA
Arm Type
Experimental
Arm Description
Healthy subjects matched to subjects in Cohort 5
Intervention Type
Drug
Intervention Name(s)
T-817MA
Intervention Description
A single oral dose of 448 mg
Primary Outcome Measure Information:
Title
Plasma concentrations
Time Frame
8 days
Title
Area under the plasma concentration time curve (AUC)
Time Frame
8 days
Title
Maximum observed plasma concentration (Cmax)
Time Frame
8 days
Title
Time to reach the maximum observed plasma concentration (tmax)
Time Frame
8 days
Title
Apparent terminal elimination rate constant
Time Frame
8 days
Title
Apparent terminal elimination half-life (t½)
Time Frame
8 days
Title
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
Time Frame
8 days
Title
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
Time Frame
8 days
Title
Metabolite to parent ratio (MPR)
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
8days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For subjects with mild, moderate or severe hepatic impairment
Adult male or female, 18 - 75 years of age
Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
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:
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.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
Female subjects who are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Preston, M.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Marbury, M.D.
Organizational Affiliation
Orlando Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PK Study of T-817 in Subjects With Hepatic Impairment
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