Healthy ParticipantsPhase 1NCT04263350
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
A Phase 1 study testing Atazanavir/Cobicistat, Reyataz Atazanavir and Cobicistat in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Atazanavir/Cobicistat, Reyataz Atazanavir and Cobicistat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 17 Nov 2020
- 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
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Women and men must agree to follow specific methods of contraception, if applicable.
Who cannot join
- History of a clinically significant drug rash or Stevens-Johnson Syndrome
- History of Gilbert's Syndrome
- Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
- Any major surgery within 4 weeks of study treatment administration
- Any gastrointestinal surgery that could impact upon the absorption of study treatment
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults
The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
- Conditions
- Healthy Participants
- Being tested
- Atazanavir/Cobicistat, Reyataz Atazanavir, Cobicistat
- Keywords
- Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir/CobicistatDrug
Also called ATV/COBI
Specified Dose on Specified Days
Reyataz AtazanavirDrug
Also called REYATAZ (ATV)
Specified Dose on Specified Days
CobicistatDrug
Also called COBI
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A:Fixed- dose combination mini-tablet | Experimental | Not described Receives: Drug: Atazanavir/Cobicistat |
| Treatment B: Separate products taken at the same time | Experimental | Not described Receives: Drug: Reyataz Atazanavir; Drug: Cobicistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)
Measured: Up to Day 10
Cmax of Cobicistat (COBI)
Measured: Up to Day 10
Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
Measured: Up to Day 10
AUC(INF) of COBI
Measured: Up to Day 10
Secondary outcomes (8)
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 70 days
Incidence of AEs leading to discontinuation
Measured: Up to 40 days
Incidence of deaths
Measured: Up to 40 days
Marked abnormalities in clinical laboratory test results
Measured: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Blood Pressure
Measured: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Heart Rate
Measured: Up to 40 days
Incidence of marked abnormalities in Electrocardiogram (ECG) recording
Measured: Up to 40 days
Incidence of Palatability questionnaire results
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start26 Feb 2020
- Primary completion12 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263350
- Sponsor's protocol ID
- AI424-567
- Status last verified
- Nov 2021
- First submitted
- 7 Feb 2020
- Last updated
- 23 Nov 2021
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults
- ClinicalTrials.gov ID
- NCT04263350
- Acronym / sponsor ID
- AI424-567
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- 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 compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A:Fixed- dose combination mini-tablet | Experimental | Drug: Atazanavir/Cobicistat |
| Treatment B: Separate products taken at the same time | Experimental | Drug: Reyataz Atazanavir, Drug: Cobicistat |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Women and men must agree to follow specific methods of contraception, if applicable.
Key exclusion criteria (6 listed)
- History of a clinically significant drug rash or Stevens-Johnson Syndrome
- History of Gilbert's Syndrome
- Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
- Any major surgery within 4 weeks of study treatment administration
- Any gastrointestinal surgery that could impact upon the absorption of study treatment
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 |
|---|---|---|
| Atazanavir/CobicistatAlso: ATV/COBISpecified Dose on Specified Days | Drug | Treatment A:Fixed- dose combination mini-tablet |
| Reyataz AtazanavirAlso: REYATAZ (ATV)Specified Dose on Specified Days | Drug | Treatment B: Separate products taken at the same time |
| CobicistatAlso: COBISpecified Dose on Specified Days | Drug | Treatment B: Separate products taken at the same time |
Primary outcome
Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)
Time frame: Up to Day 10
Cmax of Cobicistat (COBI)
Time frame: Up to Day 10
Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV
Time frame: Up to Day 10
AUC(INF) of COBI
Time frame: Up to Day 10
8 secondary outcomes
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 70 days
Incidence of AEs leading to discontinuation
Time frame: Up to 40 days
Incidence of deaths
Time frame: Up to 40 days
Marked abnormalities in clinical laboratory test results
Time frame: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Blood Pressure
Time frame: Up to 40 days
Incidence of marked abnormalities in vital sign measurements: Heart Rate
Time frame: Up to 40 days
Incidence of marked abnormalities in Electrocardiogram (ECG) recording
Time frame: Up to 40 days
Incidence of Palatability questionnaire results
Time frame: Up to 40 days
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 23 Nov 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Atazanavir/Cobicistat, Reyataz Atazanavir and Cobicistat in people with Healthy Participants, run by Bristol-Myers Squibb 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 2 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 23 Nov 2021. 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) of Atazanavir (ATV) (time frame: Up to Day 10). 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 23 Nov 2021.