Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
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|ClinicalTrials.gov Identifier: NCT04828694|
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Drug: BICX104 Drug: Vivitrol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers|
|Actual Study Start Date :||June 17, 2022|
|Estimated Primary Completion Date :||December 5, 2022|
|Estimated Study Completion Date :||March 27, 2023|
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.
Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.
Active Comparator: Vivitrol
Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.
Intramuscular injection containing 380 mg of naltrexone.
- Pharmacokinetic parameter: Cmax. [ Time Frame: 140 Days ]Maximum observed mean plasma concentration [Cmax] of naltrexone and 6-beta-naltrexol.
- Pharmacokinetic parameter: Tmax. [ Time Frame: 140 Days ]Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.
- Pharmacokinetic parameter: Css. [ Time Frame: 140 Days ]Changes in the mean observed steady state plasma concentration [Css] of naltrexone and 6-beta-naltrexol.
- Pharmacokinetic parameter: AUC [ Time Frame: 140 Days ]Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.
- Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone. [ Time Frame: 140 Days ]Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.
- Pharmacokinetic parameter: Tlast. [ Time Frame: 140 Days ]Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.
- Safety Parameter: AEs [ Time Frame: 168 Days ]Incidence and severity of adverse events (AEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828694
|Contact: Brady Granierfirstname.lastname@example.org|
|Contact: Joel Neutel, M.D.||714-550-9990||NeutelMD@OCResearchCenter.com|
|United States, California|
|Orange County Research Center||Recruiting|
|Tustin, California, United States, 92780|
|Contact: Joel Neutel, MD 714-550-9990 NeutelMD@OCResearchCenter.com|