A Food Effect Study of 60mg ER Torsemide

NCT ID: NCT03215875

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2018-03-31

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.

Conditions

Food-drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fed- 60mg ER Torsemide

Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing

Group Type: EXPERIMENTAL

Fed- 60mg ER Torsemide

Intervention Type: DRUG

60mg ER Torsemide will be given after high fat, high-calorie meal

Fasting- 60mg ER Torsemide

Adult healthy subjects will fast overnight (at least 10h) prior to dosing

Group Type: EXPERIMENTAL

Fasting- 60mg ER Torsemide

Intervention Type: DRUG

60mg ER Torsemide will be given after overnight fasting

Interventions

Fed- 60mg ER Torsemide

60mg ER Torsemide will be given after high fat, high-calorie meal

Intervention Type: DRUG

Fasting- 60mg ER Torsemide

60mg ER Torsemide will be given after overnight fasting

Intervention Type: DRUG

Other Intervention Names

High fat/high-calorie fed conditions; Fasting conditions

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sarfez Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Wilcox, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sarfez Pharmaceuticals, Inc.

Locations

I.E.C. Consultants

Bangalore, , India

Countries

India

Other Identifiers

CLCD-061-17

Identifier Type: -

Identifier Source: org_study_id