A Food Effect Study of 60mg ER Torsemide

Phase 1

Completed

• Conditions: Food-drug Interaction
• Interventions: Drug: Fed- 60mg ER Torsemide; Drug: Fasting- 60mg ER Torsemide

• Registration Number: NCT03215875
• Lead Sponsor: Sarfez Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2017-10-17
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fed- 60mg ER Torsemide	Fed- 60mg ER Torsemide	Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing
Fasting- 60mg ER Torsemide	Fasting- 60mg ER Torsemide	Adult healthy subjects will fast overnight (at least 10h) prior to dosing

Primary Outcome Measures

Name	Time	Method
Total torsemide plasma concentration	36 hours	Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions
Peak torsemide plasma concentration	36 hours	Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions

Secondary Outcome Measures

Name	Time	Method
Urinary torsemide excretion	36 hours	torsemide will be measured in urine over 36 hours post-dose (microgram/min)
Urinary sodium excretion	36 hours	36-hour sodium excretion will be measure (mmol/min)

Trial Locations

Locations (1)

I.E.C. Consultants; 🇮🇳 Bangalore, India