Infection, Human Immunodeficiency VirusPhase 1NCT02508064
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
A Phase 1 study testing BMS-663068 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United Kingdom.
Trial summary
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2015to 5 Nov 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, 18 to 50 years of age, inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
Who cannot join
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
- PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
- Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.
- 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 |
|---|---|---|
| Part 1 | Experimental | BMS-663068 1 × 600 mg extended-release (ER) tablet formulation Receives: Drug: BMS-663068 |
| Part 1: Prototype 1 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1) Receives: Drug: BMS-663068 |
| Part 1: Prototype 2 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2) Receives: Drug: BMS-663068 |
| Part 1: Prototype 3 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3) Receives: Drug: BMS-663068 |
| Part 1: Prototype 4 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4) Receives: Drug: BMS-663068 |
| Part 1: Prototype 5 | Experimental | BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5) Receives: Drug: BMS-663068 |
| Part 2 | Experimental | BMS-663068 1 × 600 mg ER tablet formulation Receives: Drug: BMS-663068 |
| Part 2: Prototype 1 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1) Receives: Drug: BMS-663068 |
| Part 2: Prototype 2 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2) Receives: Drug: BMS-663068 |
| Part 2: Prototype 3 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3) Receives: Drug: BMS-663068 |
| Part 2: Prototype 4 | Experimental | BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4) Receives: Drug: BMS-663068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of BMS-626529
Measured: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529
Measured: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529
Measured: Day 1 to Day 4 of each period
Secondary outcomes (2)
Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE)
Measured: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing
Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs
Measured: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start3 Aug 2015
- Primary completion5 Nov 2015
- Study completion5 Nov 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT02508064
- Sponsor's protocol ID
- 206288
- Other IDs
- AI438-054
- Status last verified
- Sep 2017
- First submitted
- 22 Jul 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02508064
- Acronym / sponsor ID
- 206288
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 24 Jul 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.
This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: BMS-663068BMS-663068 1 × 600 mg extended-release (ER) tablet formulation |
| Part 1: Prototype 1 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1) |
| Part 1: Prototype 2 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2) |
| Part 1: Prototype 3 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3) |
| Part 1: Prototype 4 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4) |
| Part 1: Prototype 5 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5) |
| Part 2 | Experimental | Drug: BMS-663068BMS-663068 1 × 600 mg ER tablet formulation |
| Part 2: Prototype 1 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1) |
| Part 2: Prototype 2 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2) |
| Part 2: Prototype 3 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3) |
| Part 2: Prototype 4 | Experimental | Drug: BMS-663068BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females, 18 to 50 years of age, inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
Key exclusion criteria (6 listed)
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
- Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
- Exposure to any investigational drug or placebo within 12 weeks of study drug administration
- Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
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 | Part 1, Part 1: Prototype 1, Part 1: Prototype 2, Part 1: Prototype 3, Part 1: Prototype 4, Part 1: Prototype 5, Part 2, Part 2: Prototype 1, Part 2: Prototype 2, Part 2: Prototype 3, Part 2: Prototype 4 |
Primary outcome
Maximum observed concentration (Cmax) of BMS-626529
Time frame: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529
Time frame: Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529
Time frame: Day 1 to Day 4 of each period
2 secondary outcomes
Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE)
Time frame: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing
Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs
Time frame: Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing
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 11 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 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 3 inclusion and 6 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 11 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 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?
Maximum observed concentration (Cmax) of BMS-626529 (time frame: Day 1 to Day 4 of each period). 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 11 Sep 2017.