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

• Status: Terminated
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biotie Therapies Inc.
• Collaborator: Acorda Therapeutics

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.