Infection, Human Immunodeficiency VirusPhase 1NCT02095886
Relative Bioavailability Study With BMS-955176
A Phase 1 study testing BMS-955176 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United Kingdom.
Trial summary
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further. 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-955176
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2014to 7 Jul 2014
- 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
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
Who cannot join
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
Read the detailed description
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-955176
- 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-955176Drug
BMS-955176
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
| Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) | Experimental | BMS-955176 single dose by mouth as specified Receives: Drug: BMS-955176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Secondary outcomes (4)
Time of maximum observed plasma concentration (Tmax) of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Terminal plasma half-life (T-HALF) of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Apparent total body clearance (CLT/F) of BMS-955176
Measured: Days 1-4 of Periods 1, 2, 3 and 4
Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations
Measured: Up to Period 4/Day 4 (discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start25 Mar 2014
- Primary completion7 Jul 2014
- Study completion7 Jul 2014
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT02095886
- Sponsor's protocol ID
- 206740
- Other IDs
- 2013-004896-10, AI468-034
- Status last verified
- Sep 2017
- First submitted
- 21 Mar 2014
- 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
- Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02095886
- Acronym / sponsor ID
- 206740
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 25 Mar 2014 (actual)
- Primary completion
- 7 Jul 2014 (actual)
- Study completion
- 7 Jul 2014 (actual)
- First posted
- 26 Mar 2014 (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 study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
Detailed description
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
| Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth as specified |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
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-955176BMS-955176 | Drug | Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C), Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A), Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B), Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C), Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H), Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E), Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F), Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
4 secondary outcomes
Time of maximum observed plasma concentration (Tmax) of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
Terminal plasma half-life (T-HALF) of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
Apparent total body clearance (CLT/F) of BMS-955176
Time frame: Days 1-4 of Periods 1, 2, 3 and 4
Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations
Time frame: Up to Period 4/Day 4 (discharge)
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-955176 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 4 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 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 plasma concentration (Cmax) of BMS-955176 (time frame: Days 1-4 of Periods 1, 2, 3 and 4). 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.