Hepatic ImpairmentPhase 1NCT03212313
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
A Phase 1 study testing Tozadenant in people with Hepatic Impairment, run by Biotie Therapies Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Tozadenant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2017to 31 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
About this study
Official title: A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
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
- Being tested
- Tozadenant
- Keywords
- Adults, Liver Disease
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TozadenantDrug
Two 60 mg tablets for a total single study dose of 120 mg
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Study dose of 120 mg Receives: Drug: Tozadenant |
| Mild Hepatic Impairment | Experimental | Study dose of 120 mg Receives: Drug: Tozadenant |
| Moderate Hepatic Impairment | Experimental | Study dose of 120 mg Receives: Drug: Tozadenant |
| Severe Hepatic Impairment | Experimental | Up to a maximum study dose of 120 mg Receives: Drug: Tozadenant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start30 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: New Safety Information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Responsible party
- Sponsor
- Investigators
- Richard Preston, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212313
- Sponsor's protocol ID
- TOZ-CL11
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
- ClinicalTrials.gov ID
- NCT03212313
- Acronym / sponsor ID
- TOZ-CL11
- Conditions
- Hepatic Impairment
- Keywords
- Adults, Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New Safety Information
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biotie Therapies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Acorda Therapeutics
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Drug: TozadenantStudy dose of 120 mg |
| Mild Hepatic Impairment | Experimental | Drug: TozadenantStudy dose of 120 mg |
| Moderate Hepatic Impairment | Experimental | Drug: TozadenantStudy dose of 120 mg |
| Severe Hepatic Impairment | Experimental | Drug: TozadenantUp to a maximum study dose of 120 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TozadenantTwo 60 mg tablets for a total single study dose of 120 mg | Drug | Healthy Subjects, Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment |
Primary outcome
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.
Time frame: up to 12 days
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.
1 secondary outcome
Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.
Time frame: up to 12 days
Results and safety
The study was stopped early (reason given: New Safety Information). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Preston, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tozadenant in people with Hepatic Impairment, run by Biotie Therapies Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: New Safety Information). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.