Evaluating Predictive Methods & Product Performance in Healthy Adults for Pediatric Patients, A Case Study: Furosemide

NCT03093090 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 2000020010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Absorption

Keywords

furosemide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• differences in the peak plasma concentration in furosemide (C-max)

  4 weeks

• total urinary sodium output

  4 weeks

Study Arms (4)

Water First

ACTIVE COMPARATOR

20mg furosemide administered PO with 6 oz of randomly-assigned study liquid

Dietary Supplement: Water; Dietary Supplement: Parmalat™ Whole Milk; Dietary Supplement: Similac Pro-Advance™; Dietary Supplement: Ensure Plus™; Drug: Furosemide 20 MG

Milk First

ACTIVE COMPARATOR

Parmalat™ Whole Milk 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid

Dietary Supplement: Water; Dietary Supplement: Parmalat™ Whole Milk; Dietary Supplement: Similac Pro-Advance™; Dietary Supplement: Ensure Plus™; Drug: Furosemide 20 MG

Baby formula first

ACTIVE COMPARATOR

Similac Pro-Advance™ 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid

Dietary Supplement: Water; Dietary Supplement: Parmalat™ Whole Milk; Dietary Supplement: Similac Pro-Advance™; Dietary Supplement: Ensure Plus™; Drug: Furosemide 20 MG

Ensure Plus first

ACTIVE COMPARATOR

Ensure Plus™ 20mg furosemide administered PO with 6 oz of randomly-assigned study liquid

Dietary Supplement: Water; Dietary Supplement: Parmalat™ Whole Milk; Dietary Supplement: Similac Pro-Advance™; Dietary Supplement: Ensure Plus™; Drug: Furosemide 20 MG

Interventions

Water DIETARY_SUPPLEMENT

6 oz

Baby formula first; Ensure Plus first; Milk First; Water First

Parmalat™ Whole Milk DIETARY_SUPPLEMENT

6 oz

Also known as: Milk

Baby formula first; Ensure Plus first; Milk First; Water First

Similac Pro-Advance™ DIETARY_SUPPLEMENT

6 oz

Also known as: baby formula

Baby formula first; Ensure Plus first; Milk First; Water First

Ensure Plus™ DIETARY_SUPPLEMENT

6 oz

Also known as: Ensure

Baby formula first; Ensure Plus first; Milk First; Water First

Furosemide 20 MG DRUG

Furosemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt.

Also known as: Lasix

Baby formula first; Ensure Plus first; Milk First; Water First

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40
• females and 4 males will be recruited
• Free from known significant chronic medical illness (i.e., hypertension, diabetes, atherosclerosis, chronic kidney disease, liver disease, lupus, taking medications with known interactions with furosemide, a history of syncope/falls, or any acute illness, such as influenza, gastroenteritis, dehydration, electrolyte imbalance, or thrombosis risks).
• Systolic Blood Pressure ≥90 mmHg at Screening Visit

You may not qualify if:

• Inability to read English or give informed consent
• Recent hospitalization within 6 months
• Pregnant or lactating
• Allergy or intolerance to furosemide
• Allergy or intolerance to milk, milk products or soy
• Inability to return for 4 consecutive weekly overnight visits at the study site
• Female subjects with low, or borderline low blood pressure, will be evaluated carefully prior to enrollment, to ensure the safety of all subjects involved in the research study.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Interventions

Water; Milk; Infant Formula; Ensure Plus; Furosemide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Milk Substitutes; Food, Formulated; Foods, Specialized; Infant Food; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Jeffrey Testani, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A four-way randomized crossover PK study

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: December 31, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)