HealthyPhase 1NCT04161482
An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability
A Phase 1 study testing Furosemide 80 mg (8 mg/mL) in people with Healthy, run by scPharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Furosemide 80 mg (8 mg/mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 26 Jun 2020
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible for inclusion only if all of the following criteria are met:
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female Subjects 45-80 years of age.
- Have the ability to understand the requirements of the study and is willing to comply with all study procedures.
- In the opinion of the investigator, able to participate in the study.
Who cannot join
- A Subject is not eligible for inclusion if any of the following criteria apply:
- Receipt of loop diuretics (furosemide, bumetanide or torsemide) or thiazide diuretics (hydrochlorothiazide or metolazone) within 24 hours of study drug.
- Receipt of potassium-sparing diuretics (spironolactone, amiloride) or oral calcium, potassium or magnesium supplements (including multi-vitamins) within 24 hours of study drug.
- History of allergy to furosemide, sulfonamides or other loop diuretics.
- Any skin conditions currently requiring medical therapy.
- History of diabetes.
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- Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination.
- Serum sodium <130 mEq/L at screening.
- Serum potassium < 3.5 or > 5.5 mEq/L at screening.
- Serum magnesium < 1.5 or > 2.5 mEq/L at screening.
- Serum chloride < 96 or > 106 mEq/L at screening.
- Serum calcium < 8.5 or > 10.5 mg/dL at screening.
- Estimated Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease (sMDRD) equation at screening.
- Systolic BP (SBP) < 90 mm Hg at screening or baseline.
- Heart rate > 110 beats per minute (BPM) at screening or baseline.
- History of tinnitus or hearing impairment, including deafness.
- Temperature > 38°C (oral or equivalent) at screening or baseline.
- Blood alcohol concentration > 2 mg/dL (0.02%) at screening or baseline.
- Female Subject who is pregnant or lactating.
- History of major abdominal surgery affecting the needle placement site.
- History of benign prostatic hyperplasia (BPH), prostatitis or prostate cancer.
- Urinary retention due to bladder emptying disorders and/or urethral narrowing.
- History of liver disease, cirrhosis, or ascites.
- Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
- Allergies and/or sensitivities to adhesive bandages or medical tape.
- Any surgical or medical condition which in the opinion of the Investigator may interfere with participation in the study or which may affect the outcome of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.
Read the detailed description
Furoscix 80 mg will be administered as a subcutaneous infusion following a step-wise decrease in infusion times starting with a 5 hour infusion time. Subsequent cohorts will enroll following a safety assessment of the prior cohort. While maintaining the 80 mg dose, infusion time will ultimately be reduced to 30 minutes.
- Conditions
- Healthy
- Being tested
- Furosemide 80 mg (8 mg/mL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 80 mg (8 mg/mL)Drug
Furoscix will be administered as a subcutaneous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort One | Experimental | A bi-phasic delivery over 5 hours Receives: Drug: Furosemide 80 mg (8 mg/mL) |
| Cohort 2a | Experimental | Continuous infusion over 2 hours Receives: Drug: Furosemide 80 mg (8 mg/mL) |
| Cohort 2b | Experimental | Bi-phasic delivery over 2 hours Receives: Drug: Furosemide 80 mg (8 mg/mL) |
| Cohort 3 | Experimental | Continuous infusion over 1 hour. Receives: Drug: Furosemide 80 mg (8 mg/mL) |
| Cohort 4 | Experimental | Continuous infusion over 30 minutes. Receives: Drug: Furosemide 80 mg (8 mg/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion Site Pain (11 Point Pain Scale)
Assessment of pain will be conducted upon placement of the subcutaneous (SC) needle, upon activation of SC infusion and periodically during the infusion and post-infusion completion for up to 8 hours after the start of the infusion using a standardized 11 point pain scale. Score will range from 0 to 10, where zero is equivalent to no pain and 10 is equivalent to the worst possible pain.
Measured: 8 hours
Secondary outcomes (1)
Safety (Adverse Events)
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) will be assessed from the start of study drug administration through 24-48 hours after the start of the infusion.
Measured: Hours 1-8 and at the 24-48 hour follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start2 Dec 2019
- Primary completion24 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The initial cohort (Cohort 1) will receive 80 mg (10 mL) with a bi-phasic delivery profile over 5 hours. Cohort 2a will evaluate a 2-hour infusion and Cohort 2b will be a bi-phasic delivery over 2 hours. Cohorts 3 and 4 will deliver the Furoscix over one hour and 30 minutes, respectively.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- scPharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Data Services, Inc., CSSi Life Sciences
- Responsible party
- Sponsor
- Investigators
- Samir Arora, MD, Principal investigator, Aventiv Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161482
- Sponsor's protocol ID
- scP-01-007
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability
- ClinicalTrials.gov ID
- NCT04161482
- Acronym / sponsor ID
- scP-01-007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- scPharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Data Services, Inc., CSSi Life Sciences
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 13 Nov 2019 (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.
This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.
Detailed description
Furoscix 80 mg will be administered as a subcutaneous infusion following a step-wise decrease in infusion times starting with a 5 hour infusion time. Subsequent cohorts will enroll following a safety assessment of the prior cohort. While maintaining the 80 mg dose, infusion time will ultimately be reduced to 30 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The initial cohort (Cohort 1) will receive 80 mg (10 mL) with a bi-phasic delivery profile over 5 hours. Cohort 2a will evaluate a 2-hour infusion and Cohort 2b will be a bi-phasic delivery over 2 hours. Cohorts 3 and 4 will deliver the Furoscix over one hour and 30 minutes, respectively.
| Arm | Type | Receives |
|---|---|---|
| Cohort One | Experimental | Drug: Furosemide 80 mg (8 mg/mL)A bi-phasic delivery over 5 hours |
| Cohort 2a | Experimental | Drug: Furosemide 80 mg (8 mg/mL)Continuous infusion over 2 hours |
| Cohort 2b | Experimental | Drug: Furosemide 80 mg (8 mg/mL)Bi-phasic delivery over 2 hours |
| Cohort 3 | Experimental | Drug: Furosemide 80 mg (8 mg/mL)Continuous infusion over 1 hour. |
| Cohort 4 | Experimental | Drug: Furosemide 80 mg (8 mg/mL)Continuous infusion over 30 minutes. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female Subjects 45-80 years of age.
- Have the ability to understand the requirements of the study and is willing to comply with all study procedures.
- In the opinion of the investigator, able to participate in the study.
Key exclusion criteria (26 listed)
- Receipt of loop diuretics (furosemide, bumetanide or torsemide) or thiazide diuretics (hydrochlorothiazide or metolazone) within 24 hours of study drug.
- Receipt of potassium-sparing diuretics (spironolactone, amiloride) or oral calcium, potassium or magnesium supplements (including multi-vitamins) within 24 hours of study drug.
- History of allergy to furosemide, sulfonamides or other loop diuretics.
- Any skin conditions currently requiring medical therapy.
- History of diabetes.
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 |
|---|---|---|
| Furosemide 80 mg (8 mg/mL)Furoscix will be administered as a subcutaneous infusion. | Drug | Cohort 2a, Cohort 2b, Cohort 3, Cohort 4, Cohort One |
Primary outcome
Infusion Site Pain (11 Point Pain Scale)
Time frame: 8 hours
Assessment of pain will be conducted upon placement of the subcutaneous (SC) needle, upon activation of SC infusion and periodically during the infusion and post-infusion completion for up to 8 hours after the start of the infusion using a standardized 11 point pain scale. Score will range from 0 to 10, where zero is equivalent to no pain and 10 is equivalent to the worst possible pain.
1 secondary outcome
Safety (Adverse Events)
Time frame: Hours 1-8 and at the 24-48 hour follow up visit.
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 10 Jul 2020.
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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.
Samir Arora, MD principal investigator
Aventiv Clinical Research
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 Furosemide 80 mg (8 mg/mL) in people with Healthy, run by scPharmaceuticals, Inc. at 1 site in United States.
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 5 inclusion and 26 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 10 Jul 2020. 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 United States. 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?
Infusion Site Pain (11 Point Pain Scale) (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.