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

NCT03212313 | Terminated Phase 1 FDA Drug

• 1 other identifier: TOZ-CL11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Keywords

Adults; Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 12 days

Study Arms (4)

Healthy Subjects

ACTIVE COMPARATOR

Study dose of 120 mg

Drug: Tozadenant

Mild Hepatic Impairment

EXPERIMENTAL

Study dose of 120 mg

Drug: Tozadenant

Moderate Hepatic Impairment

EXPERIMENTAL

Study dose of 120 mg

Drug: Tozadenant

Severe Hepatic Impairment

EXPERIMENTAL

Up to a maximum study dose of 120 mg

Drug: Tozadenant

Interventions

Tozadenant DRUG

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

Healthy Subjects; Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Biotie Therapies Inc.: lead
• Acorda Therapeutics: collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

tozadenant

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Richard Preston, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: June 30, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 4, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)