Hepatic Impairment
Conditions
Keywords
Adults, Liver Disease
Brief summary
This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.
Interventions
DRUGTozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Sponsors
Acorda Therapeutics
Biotie Therapies Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All subjects must fulfill the following to participate: * Subject has given his/her written informed consent on an IEC or IRB approved consent form. * Subject understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol. * Be either male or female 18 years old * Have a BMI ≥ 18.5 and ≤ 40.0 kg/m2 at screening * Is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day * Child bearing females should be sexually inactive (abstinent) prior to dosing * Females subjects of non childbearing potential must have undergone one of the following sterilization or be postmenopausal Subjects with mild, moderate, or severe hepatic impairment must: * Have a medical history consistent with a diagnosis of hepatic impairment. * Have a diagnosis of chronic (\> 6 months), stable hepatic insufficiency Healthy subjects must be: * Medically healthy with no significant medical history
Exclusion criteria
Subjects must not be enrolled in the study if they: * Previously participated in any study with tozadenant * Has orthostatic hypotension, history or symptoms of cardiovascular disease, or hypertensive crisis. * Currently participating in or has participated in another study and received drug (active or placebo) * Have a known diagnosis of malignant melanoma * Have a current episode of major depression * Has a recent history of suicide attempt * Has any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history * Had surgery or any medical condition within 6 months * Unable to refrain from or anticipates the use of any drugs, vitamins, natural or herbal supplements * Subject is currently lactating or pregnant or planning to become pregnant. * Recent donation of blood, plasma or significant blood loss * Has positive test for ethanol or drugs of abuse or a history of chronic alcohol or drug abuse * Clinically significant medical history * Positive results hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) for Healthy Volunteers only.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the pharmacokinetics (PK) [area under the time-concentration curve] of a single-dose of tozadenant in subjects with hepatic impairment to healthy subjects. | up to 12 days | To evaluate the pharmacokinetics (PK) \[area under the time-concentration curve\] of a single-dose of tozadenant in subjects with hepatic impairment compared to the PK of a single-dose of tozadenant in healthy subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations. | up to 12 days | To evaluate the safety and tolerability of a single-dose of tozadenant in subjects with hepatic impairment by physical examinations, vital sign measurements and Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire. |
Countries
United States
Outcome results
None listed