NCT03093090|WithdrawnPhase 1FDA Drug
Study Stopped
Study never officially began
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Sponsor study identifier
interventional
0
1 country
1
Study Start
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Poorly absorbed medications such as furosemide are common and recent experiments suggest that improvement in absorption can occur if these types of medications are consumed with liquids such as milk. The purpose of this study is to evaluate the absorption of furosemide in normal adults when taken with bottled water, milk (Parmalat™ Whole Milk), baby formula (Similac Pro-Advance™), or Ensure Plus™. These results will be used to make models that predict how these liquids will affect drug absorption in children, potentially providing ways to improve medication absorption in children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2017
Actual (reported)March 28, 2017
Actual (reported)December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
area under the plasma concentration curve
The primary analysis will test for overall differences in bioavailability (area under the plasma concentration curve) of furosemide between different liquids. This will be accomplished using a repeated measures ANOVA, or if the distribution is not normally distributed a Wilcoxon-matched pairs sign-rank test.
4 weeks
differences in the peak plasma concentration in furosemide (C-max)
4 weeks
total urinary sodium output
4 weeks
20mg furosemide administered PO with 6 oz of randomly-assigned study liquid
Parmalat™ Whole Milk 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid
6 oz
Yale University
New Haven, Connecticut, 06510, United States
Jeffrey Testani, MD
Yale University
0 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2017
First Posted
March 28, 2017
Study Start
December 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
Similac Pro-Advance™ 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid
Ensure Plus™ 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid
6 oz
6 oz
Furosemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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