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

Primary Purpose

Hepatic Impairment

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tozadenant

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring Adults, Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

University of Miami
Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Subjects

Mild Hepatic Impairment

Moderate Hepatic Impairment

Severe Hepatic Impairment

Arm Description

Study dose of 120 mg

Up to a maximum study dose of 120 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03212313

First Posted

June 30, 2017

Last Updated

January 2, 2018

Sponsor

Biotie Therapies Inc.

Collaborators

Acorda Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03212313

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Terminated

Why Stopped

New Safety Information

Study Start Date

June 30, 2017 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotie Therapies Inc.

Collaborators

Acorda Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Adults, Liver Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Subjects

Arm Type

Active Comparator

Arm Description

Study dose of 120 mg

Arm Title

Mild Hepatic Impairment

Arm Type

Experimental

Arm Description

Study dose of 120 mg

Arm Title

Moderate Hepatic Impairment

Arm Type

Experimental

Arm Description

Study dose of 120 mg

Arm Title

Severe Hepatic Impairment

Arm Type

Experimental

Arm Description

Up to a maximum study dose of 120 mg

Intervention Type

Drug

Intervention Name(s)

Tozadenant

Intervention Description

Two 60 mg tablets for a total single study dose of 120 mg

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

up to 12 days

Secondary Outcome Measure Information:

Title

Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.

Description

Time Frame

up to 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Preston, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809-3017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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