PK Study of T-817 in Subjects With Hepatic Impairment
Completed · Phase 1
Conditions studied: Healthy, Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT02693197
- Run by
- FUJIFILM Toyama Chemical Co., Ltd.
- People needed
- 36
- Starts
- 2016-02-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2017-11-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Miami — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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