Infection, Human Immunodeficiency VirusPhase 1NCT02576119
A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects
A Phase 1 study of Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2015to 14 Oct 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written Informed Consent
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]2
- Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
Who cannot join
- Any significant acute or chronic medical illness
- Any GI disease or surgery that can affect absorption of the study drug
- A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects
The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-955176, Placebo (Part 1), BMS-955176, Moxifloxacin, Placebo (Part 2)
- 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-955176, Placebo (Part 1)Drug
The BMS-955176 dose in sentinel Cohort 1 will be 240 mg orally. The BMS-955176 dose in sentinel Cohort 2 will be determined based on the results of data from sentinel Cohort 1.
BMS-955176, Moxifloxacin, Placebo (Part 2)Drug
Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sentinal Cohorts | Experimental | Study is in 2 sequential cohorts (BMS-955176 or placebo) each to evaluate the safety, tolerability, and PK following multiple-dose administration of BMS-955176. Receives: Drug: BMS-955176, Placebo (Part 1) |
| Part 2: Main QTc Study | Experimental | 3 period nested crossover study. Receives: Drug: BMS-955176, Moxifloxacin, Placebo (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Reported adverse events
Measured: Selected time points up to 24 hours postdose
Part 1: Vital sign measurements
Measured: Selected time points up to 24 hours postdose
Part 1: Physical examinations
Measured: Selected time points up to 24 hours postdose
Part 1: Safety 12-lead ECGs
Measured: Selected time points up to 24 hours postdose
Part 2: ΔΔQTcF, the subject specific time-matched difference between the ΔQTcF (QT interval corrected with Fridericia's method) after administration of BMS-955176 and the ΔQTcF after administration of placebo
Measured: Days 1 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start19 Oct 2015
- Primary completion26 Feb 2016
- Study completion14 Oct 2016
Why it stopped: This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 315 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
- NCT02576119
- Sponsor's protocol ID
- 206220
- Other IDs
- AI468-044
- Status last verified
- Aug 2017
- First submitted
- 13 Oct 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02576119
- Acronym / sponsor ID
- 206220
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.
- Enrolment
- 315 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 26 Feb 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 15 Oct 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.
The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sentinal Cohorts | Experimental | Drug: BMS-955176, Placebo (Part 1)Study is in 2 sequential cohorts (BMS-955176 or placebo) each to evaluate the safety, tolerability, and PK following multiple-dose administration of BMS-955176. |
| Part 2: Main QTc Study | Experimental | Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)3 period nested crossover study. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written Informed Consent
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]2
- Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness
- Any GI disease or surgery that can affect absorption of the study drug
- A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds
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-955176, Placebo (Part 1)The BMS-955176 dose in sentinel Cohort 1 will be 240 mg orally. The BMS-955176 dose in sentinel Cohort 2 will be determined based on the results of data from sentinel Cohort 1. | Drug | Part 1: Sentinal Cohorts |
| BMS-955176, Moxifloxacin, Placebo (Part 2)Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin). | Drug | Part 2: Main QTc Study |
Primary outcome
Part 1: Reported adverse events
Time frame: Selected time points up to 24 hours postdose
Part 1: Vital sign measurements
Time frame: Selected time points up to 24 hours postdose
Part 1: Physical examinations
Time frame: Selected time points up to 24 hours postdose
Part 1: Safety 12-lead ECGs
Time frame: Selected time points up to 24 hours postdose
Part 2: ΔΔQTcF, the subject specific time-matched difference between the ΔQTcF (QT interval corrected with Fridericia's method) after administration of BMS-955176 and the ΔQTcF after administration of placebo
Time frame: Days 1 to 28
Results and safety
The study was stopped early (reason given: This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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 of 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 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: stopped early, as of the sponsor's last update on 9 Aug 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 was stopped early (reason given: This study was terminated early due to neuropsychiatric serious adverse events reported by 2 participants.). Results are not available in the source record.
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?
Part 1: Reported adverse events (time frame: Selected time points up to 24 hours postdose). The study lists 5 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 9 Aug 2017.