NCT02693197

PK Study of T-817 in Subjects With Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: FUJIFILM Toyama Chemical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	T-817MA	A single oral dose of 448 mg

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-02-26
• Last updated: 2017-11-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study