Phase 1
Completed N=12
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Source: ClinicalTrials.gov NCT01404572 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir — 1.5; 1.5; 1.0 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir |
1.5; 1.5; 1.0 | — |
| PRIMARY Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir |
1.3; 1.4; 1.0 | — |
| SECONDARY Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir |
3; 3; 2 | — |
| SECONDARY Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir |
3.0; 2.8; 2.3 | — |
| SECONDARY Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests |
— | — |
| SECONDARY Number of Participants With Abnormal Findings on Electrocardiograms |
— | — |
| SECONDARY Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Vital Signs |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01404572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.