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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Active Comparator | Oral tablet |
|
| ALKS 5461 | Experimental | Sublingual tablet |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin | Drug | Single administration |
| |
| ALKS 5461 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT interval corrected for heart rate using the Fridericia formula (QTcF) | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate | Up to 14 days | |
| Incidence of abnormal ECG | Up to 13 days | |
| Tabulation of ECG morphology |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Arielle Stanford, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Overland Park | Kansas | 66212 | United States |
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C000618349 | ALKS 5461 |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Daily administration for a total of 12 dosing days |
|
| Placebo | Drug | Placebo will be matched to Moxifloxacin or ALKS 5461 |
|
Findings not present at baseline |
| Up to 14 days |
| Correlation of plasma drug levels with QT interval | Up to 14 days |
| Maximum observed plasma concentration (Cmax) for ALKS 5461 | Up to 14 days |
| Incidence of adverse events (AEs) | Up to 14 weeks |
| Change in PR interval | Up to 14 days |
| Change in QRS interval | Up to 14 days |
| Time to reach the maximum plasma concentration (Tmax) for ALKS 5461 | Up to 14 days |
| AUC(0-last): Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461 | Up to 14 days |
| AUC(0-inf): Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461 | Up to 14 days |
| Terminal elimination half-life (T1/2) for ALKS 5461 | Up to 14 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |