Infection, Human Immunodeficiency VirusPhase 1NCT02859259
A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
A Phase 1 study testing BMS-663068 (1 tablet at 600 mg) and BMS-663068 (4 tablets at 150 mg each tablet) in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-663068 (1 tablet at 600 mg) and BMS-663068 (4 tablets at 150 mg each tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2016to 12 Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent
- Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
- Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
- Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.
Who cannot join
- Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
- Exposure to any investigational drug or placebo within 4 weeks of study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability Study of BMS-626529 Administered as Prodrug BMS-663068 From 150-mg Low-dose Extended-release Tablets Compared to 600-mg Reference Extended-release Tablet in Healthy Subjects
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068 (1 tablet at 600 mg), BMS-663068 (4 tablets at 150 mg each tablet)
- 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-663068 (1 tablet at 600 mg)Drug
BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified.
BMS-663068 (4 tablets at 150 mg each tablet)Drug
BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: reference extended-release (ER) 1 tablet at 600mg | Experimental | A single dose of BMS-663068 administered orally as specified Receives: Drug: BMS-663068 (1 tablet at 600 mg) |
| Treatment B: low-dose ER 4 tablets at 150mg | Experimental | A single dose (4 tablets) of BMS-663068 administered orally as specified Receives: Drug: BMS-663068 (4 tablets at 150 mg each tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation.
Measured: Approximately 8 days
Secondary outcomes (1)
Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
Measured: Approximately 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start12 Aug 2016
- Primary completion12 Aug 2016
- Study completion12 Aug 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859259
- Sponsor's protocol ID
- 206219
- Other IDs
- AI438-080
- Status last verified
- May 2017
- First submitted
- 28 Jul 2016
- Last updated
- 15 May 2017
- 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 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability Study of BMS-626529 Administered as Prodrug BMS-663068 From 150-mg Low-dose Extended-release Tablets Compared to 600-mg Reference Extended-release Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02859259
- Acronym / sponsor ID
- 206219
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2016 (actual)
- Primary completion
- 12 Aug 2016 (actual)
- Study completion
- 12 Aug 2016 (actual)
- First posted
- 9 Aug 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.
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: reference extended-release (ER) 1 tablet at 600mg | Experimental | Drug: BMS-663068 (1 tablet at 600 mg)A single dose of BMS-663068 administered orally as specified |
| Treatment B: low-dose ER 4 tablets at 150mg | Experimental | Drug: BMS-663068 (4 tablets at 150 mg each tablet)A single dose (4 tablets) of BMS-663068 administered orally as specified |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
- Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
- Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.
Key exclusion criteria (3 listed)
- Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
- Exposure to any investigational drug or placebo within 4 weeks of study drug administration.
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-663068 (1 tablet at 600 mg)BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified. | Drug | Treatment A: reference extended-release (ER) 1 tablet at 600mg |
| BMS-663068 (4 tablets at 150 mg each tablet)BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified. | Drug | Treatment B: low-dose ER 4 tablets at 150mg |
Primary outcome
Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation.
Time frame: Approximately 8 days
1 secondary outcome
Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
Time frame: Approximately 8 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 15 May 2017.
- 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.
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 (1 tablet at 600 mg) and BMS-663068 (4 tablets at 150 mg each tablet) 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 5 inclusion and 3 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 15 May 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?
Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation. (time frame: Approximately 8 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 15 May 2017.