Study to Investigate the Influence of Hepatic Insufficien... | NCT03212313

NCT03212313

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Acorda Therapeutics	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects	Active Comparator	Study dose of 120 mg	Drug: Tozadenant
Mild Hepatic Impairment	Experimental	Study dose of 120 mg	Drug: Tozadenant
Moderate Hepatic Impairment	Experimental	Study dose of 120 mg	Drug: Tozadenant
Severe Hepatic Impairment	Experimental	Up to a maximum study dose of 120 mg	Drug: Tozadenant

Name	Type	Description	Arm Group Labels	Other Names
Tozadenant	Drug	Two 60 mg tablets for a total single study dose of 120 mg	Healthy Subjects Mild Hepatic Impairment Moderate Hepatic Impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	up to 12 days

Secondary Outcomes

Measure	Description	Time Frame
Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.	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.	up to 12 days

Eligibility Module

Eligibility Criteria

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:

Healthy subjects must be:

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.

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States
Orlando Clinical Research Center