Infection, Human Immunodeficiency VirusPhase 1NCT02805556
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
A Phase 1 study testing BMS-663068 and BMS-626529 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United Kingdom.
Trial summary
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-663068 and BMS-626529
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2016to 5 May 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- BMI 18.0-32.0 kg/m2
- Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
- Men must refrain from sperm donation for the length of the study and for 90 days
- Sign informed consent
Who cannot join
- Significant medical illness
- Tobacco use in the last 12 months
- Major surgery within 4 weeks of study administration
- Donation of blood within 4 weeks of study administration
- Current or recent (within 3 months of study administration) of gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068, BMS-626529
- 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
Single oral dose of BMS-663068
BMS-626529Drug
Single intravenous dose of [13C]BMS 626529
| Study group | Role | What they receive |
|---|---|---|
| Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529 | Experimental | Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529 Receives: Drug: BMS-663068; Drug: BMS-626529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf)
Measured: up to 11 days
Secondary outcomes (2)
Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Measured: up to 31 days
Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Measured: up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start15 Mar 2016
- Primary completion5 May 2016
- Study completion5 May 2016
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT02805556
- Sponsor's protocol ID
- 206218
- Other IDs
- AI438-075
- Status last verified
- Jul 2017
- First submitted
- 31 May 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
- ClinicalTrials.gov ID
- NCT02805556
- Acronym / sponsor ID
- 206218
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 20 Jun 2016 (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 phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529 | Experimental | Drug: BMS-663068, Drug: BMS-626529Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally healthy
- BMI 18.0-32.0 kg/m2
- Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
- Men must refrain from sperm donation for the length of the study and for 90 days
- Sign informed consent
Key exclusion criteria (5 listed)
- Significant medical illness
- Tobacco use in the last 12 months
- Major surgery within 4 weeks of study administration
- Donation of blood within 4 weeks of study administration
- Current or recent (within 3 months of study administration) of gastrointestinal disease
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-663068Single oral dose of BMS-663068 | Drug | Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529 |
| BMS-626529Single intravenous dose of [13C]BMS 626529 | Drug | Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529 |
Primary outcome
The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf)
Time frame: up to 11 days
2 secondary outcomes
Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time frame: up to 31 days
Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time frame: up to 31 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 21 Jul 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 and BMS-626529 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United Kingdom.
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 5 inclusion and 5 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 21 Jul 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 Kingdom. 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 absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf) (time frame: up to 11 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 21 Jul 2017.