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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA047925 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The HEAL Initiative (https://heal.nih.gov/) | UNKNOWN |
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This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol intramuscular depot naltrexone injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BICX104 | Experimental | BICX104 is an eroding implantable pellet that contains 1 g naltrexone and 11 mg magnesium stearate that will be inserted subcutaneously. It will be administered once for 84 days. |
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| Vivitrol | Active Comparator | Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BICX104 | Drug | Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Cmax. | Maximum observed mean plasma concentration [Cmax] of naltrexone and 6-beta-naltrexol. | 140 Days |
| Pharmacokinetic parameter: Tmax. | Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol. | 140 Days |
| Pharmacokinetic parameter: Css. | Changes in the mean observed steady state plasma concentration [Css] of naltrexone and 6-beta-naltrexol. | 140 Days |
| Pharmacokinetic parameter: AUC | Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol. | 140 Days |
| Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone. | Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml. | 140 Days |
| Pharmacokinetic parameter: Tlast. | Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol. | 140 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Parameter: AEs | Incidence and severity of adverse events (AEs) | 168 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| Vivitrol | Drug | Intramuscular injection containing 380 mg of naltrexone. |
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