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

Hepatic Impairment Clinical Trial

Official title:

A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03212313
• Other study ID #: TOZ-CL11
• Status: Terminated
• Phase: Phase 1
• First received: June 30, 2017
• Last updated: January 2, 2018
• Start date: June 30, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: Biotie Therapies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Hepatic Insufficiency

Intervention

Drug:
• Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Biotie Therapies Inc.	Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	up to 12 days
Secondary	Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.	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.	up to 12 days