Clinical trial NCT03215875: A Food Effect Study of 60mg ER Torsemide
Official title: A Randomized, Balanced, Single Dose, Two-treatment (Fed vs. Fasting), Two-period, Two-sequence, Crossover Study to Evaluate the Effects of Food on the Bioavailability of 60 mg ER Torsemide Tablet in Healthy Human Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Food-drug Interaction
Lead sponsor: Sarfez Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 60mg ER Torsemide study in fed and fasting conditions
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers. The study will be conducted as a two-sequence to period crossover study to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER torsemide is a new strength and dosage form.

Detailed description: Immediate Release (IR) Torsemide is a highly effective natriuretic drug but its short duration of action is a major drawback, which allows significant post-dose sodium retention, and as consequence, limits salt loss in patients with heart failure unless dietary salt intake is severely restricted. Extended Release (ER) torsemide is being developed to address this drawback by prolonging the duration of action to increase sodium excretion even in patients who consume high salt diet. Since 60mg ER torsemide is a new strength and dosage form, this study will test 60mg ER torsemide for a food effect in healthy volunteers who are either fasting or consuming a high-fat meal (fed). The primary endpoint of the study is full pharmacokinetics measurements after a single dose of 60mg ER torsemide. The secondary endpoints are 24h sodium excretion and total urinary excretion.

Eligibility criteria: Inclusion Criteria:

* healthy male or female
* non-smoker
* weight ≥ 50 kg for male and ≥ 45 for female
* clinically acceptable laboratory profiles with ECG and chest x-ray performed within 6 months

Exclusion Criteria:

* participation in bioavailability/bioequivalence studies in past six months
* history of drug abuse or alcohol dependence
* history of allergies, known hypersensitivity to Torsemide and related drugs
* presence of clinically significant disorder
* suffer from high/low blood pressure (\<90 and \>140 mm Hg)
* positive urine drug screening, and
* history of incontinence

Primary outcomes:
measure: Peak torsemide plasma concentration
timeFrame: 36 hours
measure: Total torsemide plasma concentration
timeFrame: 36 hours
Secondary outcomes:
measure: Urinary torsemide excretion
timeFrame: 36 hours
measure: Urinary sodium excretion
timeFrame: 36 hours
Other outcomes:
Locations:
city: Bangalore
country: India
facility: I.E.C. Consultants
Study officials:
affiliation: Sarfez Pharmaceuticals, Inc.
name: Christopher Wilcox, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: