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Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01404572
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition HIV
Interventions Drug: Atazanavir (current formulation)
Drug: Atazanavir, powder for oral use 1 (POU1)
Drug: Atazanavir (POU2)
Enrollment 12
Recruitment Details  
Pre-assignment Details A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.
Arm/Group Title Treatment Sequence A, B, C Treatment Sequence B, C, A Treatment Sequence C, A, B
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 4 4 4
Completed 4 4 4
Not Completed 0 0 0
Arm/Group Title All Treated
Hide Arm/Group Description All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
30.7  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
White 10
Black or African American 2
Asian 0
American Indian or Alaska native 0
Native Hawaiian or other Pacfic Islander 0
Other 0
1.Primary Outcome
Title Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 12 12 12
Median (Full Range)
Unit of Measure: Units on a scale
1.5
(0.5 to 2.0)
1.5
(0 to 2.0)
1.0
(0 to 2.5)
2.Primary Outcome
Title Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.3  (0.66) 1.4  (0.70) 1.0  (0.62)
3.Secondary Outcome
Title Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 12 12 12
Median (Full Range)
Unit of Measure: Units on a scale
3
(2 to 4)
3
(1 to 4)
2
(1 to 5)
4.Secondary Outcome
Title Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.0  (0.85) 2.8  (1.11) 2.3  (1.07)
5.Secondary Outcome
Title Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Hide Description [Not Specified]
Time Frame Study Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Abnormal Findings on Electrocardiograms
Hide Description [Not Specified]
Time Frame Study Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Study Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 12 12 12
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0
AEs 0 0 0
SAEs 0 0 0
8.Secondary Outcome
Title Number of Participants With Clinically Relevant Changes in Vital Signs
Hide Description [Not Specified]
Time Frame Study Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.
Arm/Group Title 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
Hide Arm/Group Description:
Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Study Day 1
Adverse Event Reporting Description This was a taste assessment study; no participants swallowed any study drug.
 
Arm/Group Title 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
Hide Arm/Group Description Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A) Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B) Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
This was a taste assessment only; participants did not swallow any treatment blends.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb (BMS)
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01404572     History of Changes
Other Study ID Numbers: AI424-466
First Submitted: July 27, 2011
First Posted: July 28, 2011
Results First Submitted: March 13, 2013
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013