Food-drug InteractionPhase 1NCT03215875

A Food Effect Study of 60mg ER Torsemide

A Phase 1 study testing Fed- 60mg ER Torsemide and Fasting- 60mg ER Torsemide in people with Food-drug Interaction, run by Sarfez Pharmaceuticals, Inc. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Food-drug Interaction
What is being tested?: Fed- 60mg ER Torsemide and Fasting- 60mg ER Torsemide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteIndia
Study dates: 17 Oct 2017to 31 Mar 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

I.E.C. Consultants
Bangalore, 560003

Other trials in India

About this study

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

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.

Read the 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
Being tested: Fed- 60mg ER Torsemide, Fasting- 60mg ER Torsemide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fed- 60mg ER TorsemideDrug
Also called High fat/high-calorie fed conditions
60mg ER Torsemide will be given after high fat, high-calorie meal
Fasting- 60mg ER TorsemideDrug
Also called Fasting conditions
60mg ER Torsemide will be given after overnight fasting

Study groups in NCT03215875
Study group	Role	What they receive
Fed- 60mg ER Torsemide	Experimental	Adult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing Receives: Drug: Fed- 60mg ER Torsemide
Fasting- 60mg ER Torsemide	Experimental	Adult healthy subjects will fast overnight (at least 10h) prior to dosing Receives: Drug: Fasting- 60mg ER Torsemide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201731 Mar 2018

First posted12 Jul 2017
Study start17 Oct 2017
Primary completion31 Mar 2018
Study completion31 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Food-drug InteractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 60mg ER Torsemide study in fed and fasting conditions
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03215875
Sponsor's protocol ID: CLCD-061-17
Status last verified: Apr 2018
First submitted: 9 Jul 2017
Last updated: 18 Apr 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Food-drug Interaction trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03215875
Acronym / sponsor ID: CLCD-061-17
Conditions: Food-drug Interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Sarfez Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 17 Oct 2017 (actual)
Primary completion: 31 Mar 2018 (actual)
Study completion: 31 Mar 2018 (actual)
First posted: 12 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 60mg ER Torsemide study in fed and fasting conditions

Arm	Type	Receives
Fed- 60mg ER Torsemide	Experimental	Drug: Fed- 60mg ER TorsemideAdult healthy subjects will be given standardized high-fat, high-calorie meal prior to dosing
Fasting- 60mg ER Torsemide	Experimental	Drug: Fasting- 60mg ER TorsemideAdult healthy subjects will fast overnight (at least 10h) prior to dosing

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fed- 60mg ER TorsemideAlso: High fat/high-calorie fed conditions60mg ER Torsemide will be given after high fat, high-calorie meal	Drug	Fed- 60mg ER Torsemide
Fasting- 60mg ER TorsemideAlso: Fasting conditions60mg ER Torsemide will be given after overnight fasting	Drug	Fasting- 60mg ER Torsemide

Primary outcome

Peak torsemide plasma concentration
Time frame: 36 hours
Peak plasma concentration (Cmax) (ng/ml) in fed and fasting conditions
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

2 secondary outcomes

Urinary torsemide excretion
Time frame: 36 hours
Urinary sodium excretion
Time frame: 36 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Individual participant dataSharing planned: No

Related trials for Food-drug Interaction

RecruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
Healthy Volunteer Study, Healthy Adults
Recruiting
Physiological and Neurocognitive Responses to Multisensory Food Cues in VR
Healthy Participants
RecruitingPhase 1
A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
Healthy Female Adults
Active, not recruitingPhase 1
A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
Healthy
RecruitingPhase 1
A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Wilcox, MD, PhD principal investigator

Sarfez Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fed- 60mg ER Torsemide and Fasting- 60mg ER Torsemide in people with Food-drug Interaction, run by Sarfez Pharmaceuticals, Inc. at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak torsemide plasma concentration (time frame: 36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.