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

Stopped early · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT03212313

Run by

Biotie Therapies Inc.

People needed

20

Starts

2017-06-30

Expected to finish

2017-12-31

Last updated by the study team

2018-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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