Infection, Human Immunodeficiency VirusPhase 1NCT02273947
Food Effect 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 assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions. 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2014to 15 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
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead 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.
United Kingdom1 site
GSK Investigational Site
Ruddington Fields, Nottinghamshire, NG11 6JS
About this study
Official title: An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
Read the detailed description
Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.
- 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
Single dose by mouth for each treatment specified
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (ABDC): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 2 (BCAD): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 3 (CDBA): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 4 (DACB): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 5 (EFHG): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 6 (FGEH): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 7 (GHFE): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 8 (HEGF): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment as specified Receives: Drug: BMS-955176 |
| Arm 9 (IJK): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 10 (JKI): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 11 (KIJ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 12 (IKJ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 13 (JIK): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 14 (KJI): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 15 (LMN): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 16 (OPQ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 17 (PQO): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 18 (QOP): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 19 (OQP): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 20 (POQ): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment specified Receives: Drug: BMS-955176 |
| Arm 21 (QPO): BMS-955176 | Experimental | BMS-955176 single dose by mouth for each treatment 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) for BMS-955176
Measured: Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
Measured: Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
Measured: Up to Day 4 of Period 4
Plasma concentration at 24 hours post-dose (C24) for BMS-955176
Measured: Up to Day 4 of Period 4
Secondary outcomes (1)
Safety and tolerability
Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)
Measured: 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 Oct 2014 (estimated)
- Study start23 Oct 2014
- Primary completion15 Aug 2016
- Study completion15 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02273947
- Sponsor's protocol ID
- 206221
- Status last verified
- Apr 2017
- First submitted
- 10 Oct 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02273947
- Acronym / sponsor ID
- 206221
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 24 Oct 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 assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
Detailed description
Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 21
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (ABDC): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 2 (BCAD): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 3 (CDBA): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 4 (DACB): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 5 (EFHG): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 6 (FGEH): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 7 (GHFE): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 8 (HEGF): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment as specified |
| Arm 9 (IJK): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 10 (JKI): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 11 (KIJ): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 12 (IKJ): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 13 (JIK): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 14 (KJI): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 15 (LMN): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 16 (OPQ): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 17 (PQO): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 18 (QOP): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 19 (OQP): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 20 (POQ): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment specified |
| Arm 21 (QPO): BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 single dose by mouth for each treatment 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 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-955176Single dose by mouth for each treatment specified | Drug | Arm 1 (ABDC): BMS-955176, Arm 10 (JKI): BMS-955176, Arm 11 (KIJ): BMS-955176, Arm 12 (IKJ): BMS-955176, Arm 13 (JIK): BMS-955176, Arm 14 (KJI): BMS-955176, Arm 15 (LMN): BMS-955176, Arm 16 (OPQ): BMS-955176, Arm 17 (PQO): BMS-955176, Arm 18 (QOP): BMS-955176, Arm 19 (OQP): BMS-955176, Arm 2 (BCAD): BMS-955176, Arm 20 (POQ): BMS-955176, Arm 21 (QPO): BMS-955176, Arm 3 (CDBA): BMS-955176, Arm 4 (DACB): BMS-955176, Arm 5 (EFHG): BMS-955176, Arm 6 (FGEH): BMS-955176, Arm 7 (GHFE): BMS-955176, Arm 8 (HEGF): BMS-955176, Arm 9 (IJK): BMS-955176 |
Primary outcome
Maximum observed plasma concentration (Cmax) for BMS-955176
Time frame: Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
Time frame: Up to Day 4 of Period 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
Time frame: Up to Day 4 of Period 4
Plasma concentration at 24 hours post-dose (C24) for BMS-955176
Time frame: Up to Day 4 of Period 4
1 secondary outcome
Safety and tolerability
Time frame: 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 17 Apr 2017.
Related trials for Infection, Human Immunodeficiency Virus
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
HIV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV
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 17 Apr 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) for BMS-955176 (time frame: Up to Day 4 of Period 4). The study lists 4 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 17 Apr 2017.