Healthy ParticipantsPhase 1NCT05236738
A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions
A Phase 1 study testing Atazanavir, Cobicistat and Atazanavir/Cobicistat Mini-tablet 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 evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in… 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 and Atazanavir/Cobicistat Mini-tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 26 Jul 2022
- 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/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
Who cannot join
- Significant acute or chronic medical illness
- History of a clinically significant drug rash, Stevens-Johnson Syndrome or Gilbert's Syndrome
- Inability to swallow oral medication
- Major surgery within 4 weeks of study treatment administration
- 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, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions
The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- Atazanavir, Cobicistat, Atazanavir/Cobicistat Mini-tablet
- Keywords
- Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtazanavirDrug
Also called ATV, Reyataz
Specified dose on specified days
CobicistatDrug
Also called COBI, Tybost
Specified dose on specified days
Atazanavir/Cobicistat Mini-tabletDrug
Also called Evotaz
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence Group 1 | Experimental | Not described Receives: Drug: Atazanavir; Drug: Cobicistat; Drug: Atazanavir/Cobicistat Mini-tablet |
| Treatment Sequence Group 2 | Experimental | Not described Receives: Drug: Atazanavir; Drug: Cobicistat; Drug: Atazanavir/Cobicistat Mini-tablet |
| Treatment Sequence Group 3 | Experimental | Not described Receives: Drug: Atazanavir; Drug: Cobicistat; Drug: Atazanavir/Cobicistat Mini-tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Measured: Up to 17 days
Secondary outcomes (12)
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 17 days
Apparent terminal plasma half-life (T-HALF)
Measured: Up to 17 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Measured: Up to 17 days
Observed plasma concentration at 24 hours (C24)
Measured: Up to 17 days
Number of participants with Adverse Events (AEs)
Measured: Up to 75 days
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 75 days
Number of participants with AEs leading to discontinuation
Measured: Up to 75 days
Number of participants with AEs leading to death
Measured: Up to 75 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 17 days
Number of participants with vital sign abnormalities
Measured: Up to 17 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 17 days
Changes in Taste Evaluation Questionnaire
Palatability evaluated on a scale from 1 (weak) to 9 (strong)
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start13 May 2022
- Primary completion5 Jul 2022
- Study completion26 Jul 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT05236738
- Sponsor's protocol ID
- AI424-578
- Status last verified
- Oct 2022
- First submitted
- 2 Feb 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions
- ClinicalTrials.gov ID
- NCT05236738
- Acronym / sponsor ID
- AI424-578
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 11 Feb 2022 (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 evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence Group 1 | Experimental | Drug: Atazanavir, Drug: Cobicistat, Drug: Atazanavir/Cobicistat Mini-tablet |
| Treatment Sequence Group 2 | Experimental | Drug: Atazanavir, Drug: Cobicistat, Drug: Atazanavir/Cobicistat Mini-tablet |
| Treatment Sequence Group 3 | Experimental | Drug: Atazanavir, Drug: Cobicistat, Drug: Atazanavir/Cobicistat Mini-tablet |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2
Key exclusion criteria (5 listed)
- Significant acute or chronic medical illness
- History of a clinically significant drug rash, Stevens-Johnson Syndrome or Gilbert's Syndrome
- Inability to swallow oral medication
- Major surgery within 4 weeks of study treatment administration
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| AtazanavirAlso: ATV, ReyatazSpecified dose on specified days | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
| CobicistatAlso: COBI, TybostSpecified dose on specified days | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
| Atazanavir/Cobicistat Mini-tabletAlso: EvotazSpecified dose on specified days | Drug | Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 17 days
12 secondary outcomes
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 17 days
Apparent terminal plasma half-life (T-HALF)
Time frame: Up to 17 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T])
Time frame: Up to 17 days
Observed plasma concentration at 24 hours (C24)
Time frame: Up to 17 days
Number of participants with Adverse Events (AEs)
Time frame: Up to 75 days
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 75 days
Number of participants with AEs leading to discontinuation
Time frame: Up to 75 days
Number of participants with AEs leading to death
Time frame: Up to 75 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 17 days
Number of participants with vital sign abnormalities
Time frame: Up to 17 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 17 days
Changes in Taste Evaluation Questionnaire
Time frame: Up to 17 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 31 Oct 2022.
- 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 and Atazanavir/Cobicistat Mini-tablet 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 1 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 31 Oct 2022. 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: Up to 17 days). 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 31 Oct 2022.