Infection, Human Immunodeficiency VirusPhase 1NCT02467335
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study testing BMS-663068 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-663068
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2015to 3 Oct 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, ages 18 to 70 years, inclusive
- BMI: 18.5 to 38 kg/m2
- Body weight great or equal to 45.5 kg
- Subjects with hepatic impairment
- Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
- Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Who cannot join
- Any major surgery within 4 weeks of study drug administration
- Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
- Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
- Presence of severe ascites or edema in subjects, as judged by the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Hamilton, New Jersey, 08690
About this study
A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-663068Drug
BMS-663068
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1. Receives: Drug: BMS-663068 |
| Hepatic Impaired Subjects - Mild Rating | Active comparator | Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. Receives: Drug: BMS-663068 |
| Hepatic Impaired Subjects - Moderate Rating | Active comparator | Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. Receives: Drug: BMS-663068 |
| Hepatic Impaired Subjects - Severe Rating | Active comparator | Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. Receives: Drug: BMS-663068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
Measured: 5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).
Measured: 5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).
Measured: 5 days
Secondary outcomes (2)
The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events.
Adverse events will be arranged by system organ class, preferred term and hepatic function group. In addition, electrocardiogram readings will be summarized by time point relative to hepatic function group, and investigator-identified abnormalities, if present, will be listed.
Measured: 5 days
The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start29 Jan 2015
- Primary completion3 Oct 2015
- Study completion3 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467335
- Sponsor's protocol ID
- 206280
- Other IDs
- AI438-053
- Status last verified
- Sep 2017
- First submitted
- 20 May 2015
- Last updated
- 25 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT02467335
- Acronym / sponsor ID
- 206280
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 29 Jan 2015 (actual)
- Primary completion
- 3 Oct 2015 (actual)
- Study completion
- 3 Oct 2015 (actual)
- First posted
- 10 Jun 2015 (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.
A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Drug: BMS-663068Healthy subjects will receive a single, oral dose of BMS-663068 on Day 1. |
| Hepatic Impaired Subjects - Mild Rating | Active comparator | Drug: BMS-663068Mildly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
| Hepatic Impaired Subjects - Moderate Rating | Active comparator | Drug: BMS-663068Moderately impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
| Hepatic Impaired Subjects - Severe Rating | Active comparator | Drug: BMS-663068Severly impaired subjects will receive a single, oral dose of BMS-663068 on Day 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, ages 18 to 70 years, inclusive
- BMI: 18.5 to 38 kg/m2
- Body weight great or equal to 45.5 kg
- Subjects with hepatic impairment
- Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
Key exclusion criteria (4 listed)
- Any major surgery within 4 weeks of study drug administration
- Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
- Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
- Presence of severe ascites or edema in subjects, as judged by the PI
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 |
|---|---|---|
| BMS-663068BMS-663068 | Drug | Healthy Subjects, Hepatic Impaired Subjects - Mild Rating, Hepatic Impaired Subjects - Moderate Rating, Hepatic Impaired Subjects - Severe Rating |
Primary outcome
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
Time frame: 5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).
Time frame: 5 days
The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).
Time frame: 5 days
2 secondary outcomes
The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events.
Time frame: 5 days
The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.
Time frame: 5 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 25 Sep 2017.
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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.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-663068 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site 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 4 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite). (time frame: 5 days). The study lists 3 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 25 Sep 2017.