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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02693197

Enrollment

Registered

2016-02-26

Start date

2016-02-29

Completion date

2016-08-31

Last updated

2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hepatic Impairment

Keywords

Hepatic Impairment

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.

Interventions

DRUGT-817MA

A single oral dose of 448 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Metabolite to parent ratio (MPR)	8 days
Plasma concentrations	8 days
Area under the plasma concentration time curve (AUC)	8 days
Maximum observed plasma concentration (Cmax)	8 days
Time to reach the maximum observed plasma concentration (tmax)	8 days
Apparent terminal elimination rate constant	8 days
Apparent terminal elimination half-life (t½)	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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026