Trial Outcomes & Findings for Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects (NCT NCT01404572)
NCT ID: NCT01404572
Last Updated: 2013-06-10
Results Overview
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.
COMPLETED
PHASE1
12 participants
Study Day 1
2013-06-10
Participant Flow
A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.
Participant milestones
| Measure |
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.
|
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.
|
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.
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|---|---|---|---|
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Overall Study
STARTED
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4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Treated
n=12 Participants
All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
|
|---|---|
|
Age Continuous
|
30.7 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacfic Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose 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.
Outcome measures
| Measure |
Atazanavir, 15 mg/5 mL, With 10% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
|
|---|---|---|---|
|
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
Interval 0.5 to 2.0
|
1.5 Units on a scale
Interval 0.0 to 2.0
|
1.0 Units on a scale
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose 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.
Outcome measures
| Measure |
Atazanavir, 15 mg/5 mL, With 10% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
|
|---|---|---|---|
|
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
|
1.4 Units on a scale
Standard Deviation 0.70
|
1.0 Units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose 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.
Outcome measures
| Measure |
Atazanavir, 15 mg/5 mL, With 10% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
|
|---|---|---|---|
|
Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
|
3 Units on a scale
Interval 2.0 to 4.0
|
3 Units on a scale
Interval 1.0 to 4.0
|
2 Units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose 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.
Outcome measures
| Measure |
Atazanavir, 15 mg/5 mL, With 10% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
|
|---|---|---|---|
|
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
|
2.8 Units on a scale
Standard Deviation 1.11
|
2.3 Units on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose of atazanavir
Outcome measures
| Measure |
Atazanavir, 15 mg/5 mL, With 10% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
|
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
n=12 Participants
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
|
|---|---|---|---|
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Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Day 1Population: All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Outcome measures
Outcome data not reported
Adverse Events
Atazanavir, 15 mg/5 mL, With 10% Aspartame
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame
Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER