Infection, Human Immunodeficiency VirusPhase 1NCT02666053
A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects
A Phase 1 study testing BMS-663068 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2016to 22 Feb 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 males and females.
- Males and females
- Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
- Women must not be breastfeeding
- Men and WOCBP must agree to follow instructions for contraception
Who cannot join
- History of any chronic or acute illness or gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- 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 HIV attachment inhibitors, famotidine or high fat meal
- History of smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
- 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 |
|---|---|---|
| Treatment A | Experimental | Single BMS-663068 tablet under fasted conditions Receives: Drug: BMS-663068 |
| Treatment B | Experimental | Single BMS-663068 tablet with a high fat meal Receives: Drug: BMS-663068 |
| Treatment C | Experimental | Single BMS-663068 tablet after a single famotidine tablet under fasted conditions Receives: Drug: BMS-663068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Days 1-12
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Measured: Days 1-12
Secondary outcomes (1)
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment.
Measured: Days 1-12; 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 posted28 Jan 2016 (estimated)
- Study start27 Jan 2016
- Primary completion22 Feb 2016
- Study completion22 Feb 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
- Enrolment
- 72 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
- NCT02666053
- Sponsor's protocol ID
- 206295
- Other IDs
- AI438-071
- Status last verified
- Sep 2017
- First submitted
- 7 Jan 2016
- Last updated
- 11 Sep 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02666053
- Acronym / sponsor ID
- 206295
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 28 Jan 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.
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BMS-663068Single BMS-663068 tablet under fasted conditions |
| Treatment B | Experimental | Drug: BMS-663068Single BMS-663068 tablet with a high fat meal |
| Treatment C | Experimental | Drug: BMS-663068Single BMS-663068 tablet after a single famotidine tablet under fasted conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Target population: Healthy males and females.
- Males and females
- Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
- Women must not be breastfeeding
Key exclusion criteria (5 listed)
- History of any chronic or acute illness or gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- 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 HIV attachment inhibitors, famotidine or high fat meal
- History of smoking
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 | Treatment A, Treatment B, Treatment C |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Days 1-12
Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
Time frame: Days 1-12
1 secondary outcome
Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
Time frame: Days 1-12; 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 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 6 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 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?
Maximum observed plasma concentration (Cmax) (time frame: Days 1-12). The study lists 2 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.