Clinical trial NCT02693197: PK Study of T-817 in Subjects With Hepatic Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hepatic Impairment
Keywords: Hepatic Impairment
Lead sponsor: FUJIFILM Toyama Chemical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2016-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma concentrations
timeFrame: 8 days
measure: Area under the plasma concentration time curve (AUC)
timeFrame: 8 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 8 days
measure: Time to reach the maximum observed plasma concentration (tmax)
timeFrame: 8 days
measure: Apparent terminal elimination rate constant
timeFrame: 8 days
measure: Apparent terminal elimination half-life (t½)
timeFrame: 8 days
measure: Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
timeFrame: 8 days
measure: Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
timeFrame: 8 days
measure: Metabolite to parent ratio (MPR)
timeFrame: 8 days
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 8days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: University of Miami
name: Richard Preston, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Orlando Clinical Research Center
name: Thomas Marbury, M.D.
role: PRINCIPAL_INVESTIGATOR
References: