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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atazanavir + 10% aspartame | Active Comparator |
| |
| Atazanavir + 4.2% aspartame | Active Comparator |
| |
| Atazanavir + 4.2% aspartame and sucralose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir (current formulation) | Drug | Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Study Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Day 1 |
| Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pra International | Lenexa | Kansas | 66219 | United States |
A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A, B, C | Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. |
| FG001 | Treatment Sequence B, C, A | Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. |
| FG002 | Treatment Sequence C, A, B | Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated | All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who tasted at least 1 dose of atazanavir | Posted | Median | Full Range | Units on a scale | Study Day 1 |
|
Study Day 1
This was a taste assessment study; no participants swallowed any study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atazanavir, 15 mg/5 mL, With 10% Aspartame | Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A) |
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This was a taste assessment only; participants did not swallow any treatment blends.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb (BMS) | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D011208 | Powders |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
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| Atazanavir, powder for oral use 1 (POU1) | Drug | Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose |
|
|
| Atazanavir (POU2) | Drug | Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose |
|
|
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. |
| Study Day 1 |
| Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests | Study Day 1 |
| Number of Participants With Abnormal Findings on Electrocardiograms | Study Day 1 |
| Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Study Day 1 |
| Number of Participants With Clinically Relevant Changes in Vital Signs | Study Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
| OG001 | Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B) |
| OG002 | Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C) |
|
|
| Secondary | 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. | All participants who tasted at least 1 dose of atazanavir | Posted | Median | Full Range | Units on a scale | Study Day 1 |
|
|
|
| Secondary | 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. | All participants who tasted at least 1 dose of atazanavir | Posted | Mean | Standard Deviation | Units on a scale | Study Day 1 |
|
|
|
| Primary | 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. | All participants who tasted at least 1 dose of atazanavir | Posted | Mean | Standard Deviation | Units on a scale | Study Day 1 |
|
|
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| Secondary | Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests | All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends. | Posted | Study Day 1 |
|
|
| Secondary | Number of Participants With Abnormal Findings on Electrocardiograms | All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends. | Posted | Study Day 1 |
|
|
| Secondary | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All participants who tasted at least 1 dose of atazanavir | Posted | Number | Participants | Study Day 1 |
|
|
|
| Secondary | Number of Participants With Clinically Relevant Changes in Vital Signs | All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends. | Posted | Study Day 1 |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B) | 0 | 12 | 0 | 12 |
| EG002 | Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C) | 0 | 12 | 0 | 12 |
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
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| SAEs |
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