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 |
|---|---|
| Akcea Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volanesorsen, Intravenous (IV) | Experimental | 300 mg of volanesorsen (ISIS 304801) administered Intravenous (IV) single dose |
|
| Volanesorsen, Subcutaneous (SQ) | Experimental | 300 mg of volanesorsen (ISIS 304801) administered Subcutaneous (SQ) single dose |
|
| Moxifloxacin Hydrochloride | Active Comparator | Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose |
|
| Placebo Intravenous (IV) single dose | Placebo Comparator | Administered as normal saline (0.9% Sodium Chloride) |
|
| Placebo Subcutaneous (SC) single dose | Placebo Comparator | Administered as normal saline (0.9% Sodium Chloride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volanesorsen | Drug | ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval) | ECG monitoring up to 24 hours post dose | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo corrected change from baseline heart rate (HR, PR and QRS) | ECG monitoring 24 hours post dose | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Volanesorse plasma pharmacokinetics (PK) | Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h) | 0 to 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
Not provided
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000593612 | ISIS 304801 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Moxifloxacin | Drug | Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose |
|
| Placebo | Drug |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |