Trials / Completed
CompletedNCT04161482
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- scPharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Furosemide 80 mg (8 mg/mL) | Furoscix will be administered as a subcutaneous infusion. |
Timeline
- Start date
- 2019-12-02
- Primary completion
- 2020-06-24
- Completion
- 2020-06-26
- First posted
- 2019-11-13
- Last updated
- 2020-07-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04161482. Inclusion in this directory is not an endorsement.