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 studied for opioid dependence. It has also been evaluated in a Phase 2 trial that enrolled participants with opioid dependence, opioid related disorders, and cocaine dependence. It is not approved for any indication and remains in clinical development.
RBP-8000 is being developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. Indivior is the sponsor of the clinical program for this investigational small molecule in the psychiatry therapeutic area.
RBP-8000 is in Phase 2 development. One Phase 2 trial has been completed, and there are currently no active trials. The program remains investigational and has not been approved by the FDA for any indication.
RBP-8000 has been studied in one completed Phase 2 trial, NCT01846481. This randomized, double-blind, placebo-controlled study enrolled 40 participants in the United States and included individuals with opioid dependence, opioid related disorders, and cocaine dependence. The trial is listed as completed.