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NCT01404572 · ClinicalTrials.gov registry record · Phase 1
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
A Phase 1 study of HIV, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01404572: Completed Phase 1 study of HIV, sponsored by Bristol-Myers Squibb.
NCT01404572 is a Phase 1 study of HIV that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 12 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404572, a Phase 1 study of HIV, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 ex
Conditions Studied
Interventions
- DRUG Atazanavir (current formulation)
- DRUG Atazanavir, powder for oral use 1 (POU1)
- DRUG Atazanavir (POU2)
Study Locations (1)
Kansas
- Pra International - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01404572 record still lists
NCT01404572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (97% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 3 interventions - of which Atazanavir (current formulation) is the first listed.
NCT01404572 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01404572 about?
NCT01404572 is a clinical study titled "Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects". 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.
What is the current status of trial NCT01404572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-08. Estimated completion is 2011-09.
What conditions does trial NCT01404572 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01404572?
The interventions under investigation include: Atazanavir (current formulation) (DRUG), Atazanavir, powder for oral use 1 (POU1) (DRUG), Atazanavir (POU2) (DRUG).
Who is sponsoring clinical trial NCT01404572?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01404572 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01404572's enrollment target sits among peer trials
12 293rd of 303 higher than 7 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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