PK Study of T-817 in Subjects With Hepatic Impairment

Phase 1

Completed

• Conditions: Healthy; Hepatic Impairment
• Interventions: Drug: T-817MA

• Registration Number: NCT02693197
• Lead Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-26
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1:T-817MA	T-817MA	Mild hepatic impairment subjects
Cohort 2:T-817MA	T-817MA	Healthy subjects matched to subjects in Cohort 1
Cohort 3:T-817MA	T-817MA	Moderate hepatic impairment subjects
Cohort 4:T-817MA	T-817MA	Healthy subjects matched to subjects in Cohort 3
Cohort 5 :T-817MA	T-817MA	Severe hepatic impairment subjects
Cohort 6:T-817MA	T-817MA	Healthy subjects matched to subjects in Cohort 5

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	8days

Trial Locations

Locations (2)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States