PK Study of T-817 in Subjects With Hepatic Impairment

Status:	Completed
Conditions:	Healthy Studies, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Other
Healthy:	No
Age Range:	18 - 75
Updated:	11/25/2017
Start Date:	February 2016
End Date:	August 2016

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

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.

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.

We found this trial at

sites

Orlando Clinical Research Center

5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806

407-240-7878