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A Food Effect Study of 60mg ER Torsemide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215875
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Food-drug Interaction Drug: Fed- 60mg ER Torsemide Drug: Fasting- 60mg ER Torsemide Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 60mg ER Torsemide study in fed and fasting conditions
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Torsemide

Arm Intervention/treatment
Experimental: Fed- 60mg ER Torsemide
Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing
Drug: Fed- 60mg ER Torsemide
60mg ER Torsemide will be given after high fat, high-calorie meal
Other Name: High fat/high-calorie fed conditions

Experimental: Fasting- 60mg ER Torsemide
Adult healthy subjects will fast overnight (at least 10h) prior to dosing
Drug: Fasting- 60mg ER Torsemide
60mg ER Torsemide will be given after overnight fasting
Other Name: Fasting conditions




Primary Outcome Measures :
  1. Peak torsemide plasma concentration [ Time Frame: 36 hours ]
    Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions

  2. Total torsemide plasma concentration [ Time Frame: 36 hours ]
    Area under the plasma concentration versus time curve (AUC) (hr/ng/ml) in fed and fasting conditions


Secondary Outcome Measures :
  1. Urinary torsemide excretion [ Time Frame: 36 hours ]
    torsemide will be measured in urine over 36 hours post-dose (microgram/min)

  2. Urinary sodium excretion [ Time Frame: 36 hours ]
    36-hour sodium excretion will be measure (mmol/min)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215875


Locations
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India
I.E.C. Consultants
Bangalore, India, 560003
Sponsors and Collaborators
Sarfez Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Christopher Wilcox, MD, PhD Sarfez Pharmaceuticals, Inc.

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Responsible Party: Sarfez Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03215875    
Other Study ID Numbers: CLCD-061-17
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Torsemide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action