Clinical trial NCT03212313: Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
Official title: A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Adults
Liver Disease
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Acorda Therapeutics
First posted: 2017-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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:

* 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.

Primary outcomes:
measure: 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.
timeFrame: up to 12 days
Secondary outcomes:
measure: Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.
timeFrame: up to 12 days
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, MD
role: PRINCIPAL_INVESTIGATOR
References: