HIV
Conditions
Brief 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.
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
Interventions
DRUGAtazanavir (current formulation)
Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
DRUGAtazanavir, powder for oral use 1 (POU1)
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose
DRUGAtazanavir (POU2)
Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria: * 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
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir | Study Day 1 | 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. |
| Number of Participants With Clinically Relevant Changes in Vital Signs | Study Day 1 | — |
| Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Study Day 1 | — |
| Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | Study Day 1 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Treated |
|---|---|
| Age Continuous | 30.7 years STANDARD_DEVIATION 8.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacfic Islander | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants |
| Race/Ethnicity, Customized White | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
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.
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.3 Units on a scale | Standard Deviation 0.66 |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.4 Units on a scale | Standard Deviation 0.7 |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.0 Units on a scale | Standard Deviation 0.62 |
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.
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.5 Units on a scale |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.5 Units on a scale |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 1.0 Units on a scale |
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.
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 3.0 Units on a scale | Standard Deviation 0.85 |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 2.8 Units on a scale | Standard Deviation 1.11 |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir | 2.3 Units on a scale | Standard Deviation 1.07 |
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.
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir | 3 Units on a scale |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir | 3 Units on a scale |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir | 2 Units on a scale |
Secondary
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 10% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose | Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
Secondary
Number of Participants With Abnormal Findings on Electrocardiograms
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Secondary
Number of Participants With Clinically Relevant Changes in Vital Signs
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Secondary
Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Time frame: Study Day 1
Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.