Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired SubjectsPhase 1NCT01916993
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
A Phase 1 study testing NBI-98854 50 mg capsule in people with Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects, run by Neurocrine Biosciences at 3 sites in United States.
Trial summary
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
- What is being tested?
- NBI-98854 50 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2013to Dec 2013
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age.
- Healthy volunteers must be in good general health.
- Subjects with hepatic impairment must be judged to be in stable condition.
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
- Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.
- Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive).
Who cannot join
- Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
- Have a known history of neuroleptic malignant syndrome.
- Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result.
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start.
- Have had previous exposure with NBI-98854.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
Davita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.
- Being tested
- NBI-98854 50 mg capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-98854 50 mg capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | single dose of NBI-98854 50 mg capsule Receives: Drug: NBI-98854 50 mg capsule |
| Mild Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule Receives: Drug: NBI-98854 50 mg capsule |
| Moderate Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule Receives: Drug: NBI-98854 50 mg capsule |
| Severe Hepatic Impairment | Experimental | single dose of NBI-98854 50 mg capsule Receives: Drug: NBI-98854 50 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
Measured: 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose
Number of Participants with Adverse Events following dosing with NBI-98854
Measured: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired SubjectsStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris O'Brien, MD, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916993
- Sponsor's protocol ID
- NBI-98854-1303
- Status last verified
- Jan 2014
- First submitted
- 2 Aug 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT01916993
- Acronym / sponsor ID
- NBI-98854-1303
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Aug 2013 (estimated)
- 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.
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: NBI-98854 50 mg capsulesingle dose of NBI-98854 50 mg capsule |
| Mild Hepatic Impairment | Experimental | Drug: NBI-98854 50 mg capsulesingle dose of NBI-98854 50 mg capsule |
| Moderate Hepatic Impairment | Experimental | Drug: NBI-98854 50 mg capsulesingle dose of NBI-98854 50 mg capsule |
| Severe Hepatic Impairment | Experimental | Drug: NBI-98854 50 mg capsulesingle dose of NBI-98854 50 mg capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 to 75 years of age.
- Healthy volunteers must be in good general health.
- Subjects with hepatic impairment must be judged to be in stable condition.
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
- Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.
Key exclusion criteria (7 listed)
- Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
- Have a known history of neuroleptic malignant syndrome.
- Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result.
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
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 |
|---|---|---|
| NBI-98854 50 mg capsule | Drug | Healthy Volunteers, Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment |
Primary outcome
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
Time frame: 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose
Number of Participants with Adverse Events following dosing with NBI-98854
Time frame: Up to 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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.
Chris O'Brien, MD study director
Neurocrine Biosciences
3 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 NBI-98854 50 mg capsule in people with Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects, run by Neurocrine Biosciences at 3 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 (time frame: 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose). The study lists 2 primary outcomes in all. 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 16 Jan 2014.