Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RBP-8000 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| RBP-8000 100mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 100mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 100mg intravenous infusion of RBP-8000 |
| RBP-8000 200mg/Placebo | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 Day 6: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo |
| Placebo/RBP-8000 200mg | EXPERIMENTAL | Day 1: 50mg intravenous infusion of cocaine Day 3: 50mg intravenous infusion of cocaine followed by an intravenous infusion of placebo Day 6: 50mg intravenous infusion of cocaine followed by a 200mg intravenous infusion of RBP-8000 |
| Name | Type | Description |
|---|---|---|
| RBP-8000 100 mg | DRUG | RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
| Placebo | DRUG | IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6. |
| Cocaine | DRUG | 50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6. |
| RBP-8000 200 mg | DRUG | RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6 |
Inclusion Criteria: * Male and female volunteers aged 21-50 years, inclusive * Body mass index (BMI)18-32 kg/m\^2 and weight of at least 50 kg * Not currently seeking treatment for substance abuse or substance dependence * Subject is healthy, in the opinion of the Principal Investigator other than ...
RBP-8000 is an investigational small molecule being developed for opioid dependence. It is also being studied in the context of cocaine dependence and opioid-related disorders. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
RBP-8000 is being developed by Indivior Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker INDV. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating opioid dependence.
RBP-8000 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The drug is being studied for its potential to treat opioid dependence and related disorders.
RBP-8000 has one completed Phase 2 clinical trial registered under NCT01846481. This was a randomized, double-blind, placebo-controlled study involving 40 participants in the United States. The trial enrolled adults aged 21 years and older with opioid dependence, opioid-related disorders, or cocaine dependence.
RBP-8000 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being developed by Indivior Pharmaceuticals for the treatment of opioid dependence.