Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01404572
First received: July 27, 2011
Last updated: May 3, 2013
Last verified: May 2013
Results First Received: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: HIV
Interventions: Drug: Atazanavir (current formulation)
Drug: Atazanavir, powder for oral use 1 (POU1)
Drug: Atazanavir (POU2)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 12 participants were enrolled in this study, and all 12 received study drug within each treatment sequence.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Treatment Sequence A, B, C     Treatment Sequence B, C, A     Treatment Sequence C, A, B  
STARTED     4     4     4  
COMPLETED     4     4     4  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Baseline Measures
    All Treated  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  30.7  ± 8.56  
Gender  
[units: participants]
 
Female     2  
Male     10  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     12  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: 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  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir   [ Time Frame: Study Day 1 ]

4.  Secondary:   Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir   [ Time Frame: Study Day 1 ]

5.  Secondary:   Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests   [ Time Frame: Study Day 1 ]

6.  Secondary:   Number of Participants With Abnormal Findings on Electrocardiograms   [ Time Frame: Study Day 1 ]

7.  Secondary:   Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Study Day 1 ]

8.  Secondary:   Number of Participants With Clinically Relevant Changes in Vital Signs   [ Time Frame: Study Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a taste assessment only; participants did not swallow any treatment blends.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb (BMS)
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01404572     History of Changes
Other Study ID Numbers: AI424-466
Study First Received: July 27, 2011
Results First Received: March 13, 2013
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration