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ALKS 33-BUP · 1 trial · 1 indication
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...
ALKS 33-BUP is an investigational small molecule being studied for the treatment of cocaine abuse. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and pharmacodynamic effects when administered alone and when co-administered with cocaine.
ALKS 33-BUP is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company is conducting clinical research to evaluate the drug's potential in treating cocaine abuse.
ALKS 33-BUP is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for cocaine abuse.
ALKS 33-BUP has one completed clinical trial, NCT01366001, titled 'ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine.' This Phase 1 study enrolled 33 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
ALKS 33-BUP is the drug being studied in the clinical trial ALK33BUP-101, which is the trial identifier for NCT01366001. The trial name refers to the study of ALKS 33-BUP, not an alternative name for the drug itself.