Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Trial Data Services, Inc. | UNKNOWN |
| CSSi Life Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort One | Experimental | A bi-phasic delivery over 5 hours |
|
| Cohort 2a | Experimental | Continuous infusion over 2 hours |
|
| Cohort 2b | Experimental | Bi-phasic delivery over 2 hours |
|
| Cohort 3 | Experimental | Continuous infusion over 1 hour. |
|
| Cohort 4 | Experimental | Continuous infusion over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide 80 mg (8 mg/mL) | Drug | Furoscix will be administered as a subcutaneous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hours 1-8 and at the 24-48 hour follow up visit. |
Not provided
Inclusion Criteria:
Subjects are eligible for inclusion only if all of the following criteria are met:
Exclusion Criteria:
A Subject is not eligible for inclusion if any of the following criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samir Arora, MD | Aventiv Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventiv Clinical Research | Columbus | Ohio | 42313 | United States |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided