Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

Biotie Therapies

Status and phase: Terminated; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Tozadenant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03212313

TOZ-CL11

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Healthy Subjects

Active Comparator group

Description:

Study dose of 120 mg

Treatment:

Drug: Tozadenant

Mild Hepatic Impairment

Experimental group

Description:

Study dose of 120 mg

Treatment:

Drug: Tozadenant

Moderate Hepatic Impairment

Experimental group

Description:

Study dose of 120 mg

Treatment:

Drug: Tozadenant

Severe Hepatic Impairment

Experimental group

Description:

Up to a maximum study dose of 120 mg

Treatment:

Drug: Tozadenant