HIVPhase 1NCT01404572
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
A Phase 1 study testing Atazanavir (current formulation), Atazanavir, powder for oral use 1 (POU1) and Atazanavir (POU2) in people with HIV, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Atazanavir (current formulation), Atazanavir, powder for oral use 1 (POU1) and Atazanavir (POU2)
- 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 States
- Study dates
- Aug 2011to Sep 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy men and women, ages 18 to 49, inclusive
- Nonsmokers
- Women not pregnant or breastfeeding
- Participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening
Who cannot join
- Any significant acute or chronic medical illness
- Any acute or chronic condition that may have altered taste sensory perception
- Any major surgery or trauma within 4 weeks of Day 1
- Blood transfusion within 4 weeks of study participation
- Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse
- Positive urine drug screen
Show all 9Show fewer
- Positive urine screen for cotinine
- Positive hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus antibodies
- Clinically significant elevations in results of liver function tests above normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects
The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.
Read the detailed description
This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study
- Conditions
- HIV
- Being tested
- Atazanavir (current formulation), Atazanavir, powder for oral use 1 (POU1), Atazanavir (POU2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir (current formulation)Drug
Also called Reyataz
Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
Atazanavir, powder for oral use 1 (POU1)Drug
Also called Reyataz
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose
Atazanavir (POU2)Drug
Also called Reyataz
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
| Study group | Role | What they receive |
|---|---|---|
| Atazanavir + 10% aspartame | Active comparator | Not described Receives: Drug: Atazanavir (current formulation) |
| Atazanavir + 4.2% aspartame | Active comparator | Not described Receives: Drug: Atazanavir, powder for oral use 1 (POU1) |
| Atazanavir + 4.2% aspartame and sucralose | Active comparator | Not described Receives: Drug: Atazanavir (POU2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
Measured: Study Day 1
Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
Measured: Study Day 1
Secondary outcomes (6)
Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.
Measured: Study Day 1
Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.
Measured: Study Day 1
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Measured: Study Day 1
Number of Participants With Abnormal Findings on Electrocardiograms
Measured: Study Day 1
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Study Day 1
Number of Participants With Clinically Relevant Changes in Vital Signs
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT01404572
- Sponsor's protocol ID
- AI424-466
- Status last verified
- May 2013
- First submitted
- 27 Jul 2011
- Last updated
- 10 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Crossover Taste Assessment Study of Two Atazanavir Powder Formulations As Compared to a Reference Atazanavir Powder Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01404572
- Acronym / sponsor ID
- AI424-466
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Posted 10 Jun 2013
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 sweetness of 2 new atazanavir powder for oral use (POU) formulations to the current atazanavir POU in healthy participants and to select 1 atazanavir POU that has the sweetness most similar to the current atazanavir POU.
Detailed description
This study is a taste assessment study designed to select a new atazanavir powder for oral use (POU) formulation that is similar in sweetness to the current POU formulation. Participants were to taste and then spit out the POU formulations, without swallowing them. Study Classification: Other. This is a taste study
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atazanavir + 10% aspartame | Active comparator | Drug: Atazanavir (current formulation) |
| Atazanavir + 4.2% aspartame | Active comparator | Drug: Atazanavir, powder for oral use 1 (POU1) |
| Atazanavir + 4.2% aspartame and sucralose | Active comparator | Drug: Atazanavir (POU2) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women, ages 18 to 49, inclusive
- Nonsmokers
- Women not pregnant or breastfeeding
- Participants who could match solutions of the same sweetness and provide consistent sweetness scores during the taste screening
Key exclusion criteria (9 listed)
- Any significant acute or chronic medical illness
- Any acute or chronic condition that may have altered taste sensory perception
- Any major surgery or trauma within 4 weeks of Day 1
- Blood transfusion within 4 weeks of study participation
- Recent (within 6 months of Day 1) drug or alcohol abuse as defined in the Diagnostic and Statistical Manual, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse
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 (current formulation)Also: ReyatazSolution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose | Drug | Atazanavir + 10% aspartame |
| Atazanavir, powder for oral use 1 (POU1)Also: ReyatazSolution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose | Drug | Atazanavir + 4.2% aspartame |
| Atazanavir (POU2)Also: ReyatazSolution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose | Drug | Atazanavir + 4.2% aspartame and sucralose |
Primary outcome
Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Time frame: Study Day 1
Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Time frame: Study Day 1
Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.
6 secondary outcomes
Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
Time frame: Study Day 1
Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Time frame: Study Day 1
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Time frame: Study Day 1
Number of Participants With Abnormal Findings on Electrocardiograms
Time frame: Study Day 1
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Study Day 1
Number of Participants With Clinically Relevant Changes in Vital Signs
Time frame: Study Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 (current formulation), Atazanavir, powder for oral use 1 (POU1) and Atazanavir (POU2) in people with HIV, 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 4 inclusion and 9 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 10 Jun 2013. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir (time frame: Study Day 1). 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 10 Jun 2013.