Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
- Registration Number
- NCT03212313
- Lead Sponsor
- Biotie Therapies Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Mild Hepatic Impairment Tozadenant Study dose of 120 mg Moderate Hepatic Impairment Tozadenant Study dose of 120 mg Severe Hepatic Impairment Tozadenant Up to a maximum study dose of 120 mg Healthy Subjects Tozadenant Study dose of 120 mg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States