Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01366001 | ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine | PHASE1 | COMPLETED | 33 | — | — | Aug 1, 2011 | Feb 1, 2012 | Mar 9, 2012 | 1 | United States |
For safety, the primary outcome measures are AEs and cardiovascular responses (Heart Rate, Blood Pressure, Electrocardiogram) collected during cocaine infusions at baseline and during treatment with ALKS 33-BUP, ALKS 33 and placebo.
| Arm | Type | Description |
|---|---|---|
| ALKS 33-BUP | EXPERIMENTAL | - |
| ALKS 33 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALKS 33-BUP | DRUG | Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days. |
| ALKS 33 | DRUG | Sublingual administration, ALKS 33 administered once daily for 10 consecutive days. |
| Placebo | DRUG | Sublingual administration, Placebo administered once daily for 10 consecutive days. |
Inclusion Criteria In order to participate in the study, subjects must: 1. Be volunteers who are not seeking treatment for drug addiction. 2. Be between 21 and 50 years of age, inclusive. 3. Have a body mass index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2), inclusive...