Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
NCT ID: NCT03212313
Last Updated: 2018-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
20 participants
INTERVENTIONAL
2017-06-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Healthy Subjects
Study dose of 120 mg
Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Mild Hepatic Impairment
Study dose of 120 mg
Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Moderate Hepatic Impairment
Study dose of 120 mg
Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Severe Hepatic Impairment
Up to a maximum study dose of 120 mg
Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Interventions
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Tozadenant
Two 60 mg tablets for a total single study dose of 120 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Acorda Therapeutics
INDUSTRY
Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Preston, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Countries
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Other Identifiers
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TOZ-CL11
Identifier Type: -
Identifier Source: org_study_id
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