A Food Effect Study of 60mg ER Torsemide

NCT03215875 | Completed Phase 1 FDA Drug

• 1 other identifier: CLCD-061-17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Food-drug Interaction

Outcome Measures

Primary Outcomes (2)

• Peak torsemide plasma concentration

  Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions

  36 hours

• Total torsemide plasma concentration

  Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions

  36 hours

Secondary Outcomes (2)

• Urinary torsemide excretion

  36 hours

• Urinary sodium excretion

  36 hours

Study Arms (2)

Fed- 60mg ER Torsemide

EXPERIMENTAL

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

Drug: Fed- 60mg ER Torsemide

Fasting- 60mg ER Torsemide

EXPERIMENTAL

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

Drug: Fasting- 60mg ER Torsemide

Interventions

Fed- 60mg ER Torsemide DRUG

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

Also known as: High fat/high-calorie fed conditions

Fed- 60mg ER Torsemide

Fasting- 60mg ER Torsemide DRUG

60mg ER Torsemide will be given after overnight fasting

Also known as: Fasting conditions

Fasting- 60mg ER Torsemide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

I.E.C. Consultants

Bangalore, 560003, India

Location

Study Officials

• Christopher Wilcox, MD, PhD

  Sarfez Pharmaceuticals, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 60mg ER Torsemide study in fed and fasting conditions

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 12, 2017
• Study Start: October 17, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)