Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 59
• Participant gender: Both

Summary

The proposed single-dose study aims to evaluate the product design clinical performance of the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination Product, in adult Subjects previously diagnosed with mild to advanced heart failure.

The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.

The objectives of this study are:

• To demonstrate that the to-be-marketed drug-device combination product performs as intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area

• To assess safety and local tolerance of the drug-device combination product

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: scPharmaceuticals, Inc.
• Treatments: Furosemide
• Last Updated: 2016-06-14

Criteria

Inclusion Criteria:

1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.

2. Male and female Subjects ≥18 years of age

3. New York Heart Association (NYHA) Class II-IV Heart Failure.

4. In the opinion of the Investigator, able to participate in the study.

5. If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not permitted).

6. If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment.

7. Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.

Exclusion Criteria:

1. Contraindication to furosemide.

2. History of chronic skin conditions requiring medical therapy.

3. Skin reaction to medical adhesives or history of poor skin adherence of adhesives.

4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.

5. Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.

6. Clinically significant abnormalities at Screening in safety laboratory tests.

7. Hypokalemia - Potassium of < 3.6 mmol/L.

8. Systolic BP (SBP) < 90 mm Hg.

9. Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.

10. History of major abdominal surgery affecting the site of device placement.

11. Participation in another trial, within 30 days prior to Screening.

12. History of hepatitis B, hepatitis C, or HIV

13. Evidence of current or recent alcohol abuse.

14. Female Subject who is pregnant or lactating.

15. Any surgical or medical condition that -in the opinion of the Investigator - may interfere with participation in the study or that may affect the outcome of the study.