Opioid-use DisorderPhase 1NCT04828694
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
A Phase 1 study testing BICX104 and Vivitrol in people with Opioid-use Disorder, run by BioCorRx Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- BICX104 and Vivitrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 22 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent.
- Female or male subjects aged 18-50 years old.
- Without current non-remitted DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) - Substance Use Disorders diagnoses; subjects with a sustained remission diagnosis are not excluded.
- In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
- Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
- Must agree to comply with all study requirements and be willing to complete entire study.
- Females of childbearing potential and males willing to practice an effective method(s) of birth control for the duration of participation in the study (<1% failure rate per year).
Who cannot join
- Is pregnant, is planning to become pregnant or breastfeed infants during the study.
- Is currently treated with naltrexone or has had a naltrexone implant in the past 2 years or received Vivitrol treatment in the past year.
- Clinically significant medical/psychological condition or abnormality at screening (i.e., physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings), including any diagnosis of Hepatitis B, Hepatitis C or HIV infection.
- Presence of opiates, cocaine, methamphetamine or other significant drugs of abuse in the urine (as determined by urine drug test).
- Any active hepatitis or hepatic failure or dysfunction evidenced by the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 1.5 times the upper limit of normal (1.5xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 2.5xULN, prolonged prothrombin time (international normalized ratio ≥1.7), ascites, or esophageal variceal disease.
- Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric or neurological disorders that would compromise ability to complete the study.
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- Participation in a methadone program currently or within past 3 years, or 3 or more previous medically supervised detoxification treatments in past 3 years.
- If a healthy volunteer fails one naloxone challenge, the subject will not be suitable for the study. The only exceptions will be made when a 'false positive' test result is received for the first test.
- Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG).
- Participation in a clinical trial within 30 days of screening.
- Has a condition which requires or may require treatment with opioid based medication.
- Is prone to skin rashes, irritation or has a chronic skin condition.
- Alcohol Use Disorder diagnosis.
- Has a predisposition to poor response to an implant site reaction, as judged by the study physician.
- Has a history of keloid formation, connective tissue disease, e.g., scleroderma, or history of recurrent MRSA infections.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
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
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.
- Conditions
- Opioid-use Disorder
- Being tested
- BICX104, Vivitrol
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BICX104Drug
Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.
VivitrolDrug
Intramuscular injection containing 380 mg of naltrexone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BICX104 |
| Vivitrol | Active comparator | Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days. Receives: Drug: Vivitrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: Cmax.
Maximum observed mean plasma concentration [Cmax] of naltrexone and 6-beta-naltrexol.
Measured: 140 Days
Pharmacokinetic parameter: Tmax.
Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.
Measured: 140 Days
Pharmacokinetic parameter: Css.
Changes in the mean observed steady state plasma concentration [Css] of naltrexone and 6-beta-naltrexol.
Measured: 140 Days
Pharmacokinetic parameter: AUC
Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.
Measured: 140 Days
Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone.
Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.
Measured: 140 Days
Pharmacokinetic parameter: Tlast.
Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.
Measured: 140 Days
Secondary outcomes (1)
Safety Parameter: AEs
Incidence and severity of adverse events (AEs)
Measured: 168 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start17 Jun 2022
- Primary completion22 Feb 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCorRx Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), The HEAL Initiative (https://heal.nih.gov/)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828694
- Sponsor's protocol ID
- BioCorRx-21-01a
- Other IDs
- UG3DA047925
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04828694
- Acronym / sponsor ID
- BioCorRx-21-01a
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BioCorRx IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), The HEAL Initiative (https://heal.nih.gov/)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BICX104 | Experimental | Drug: BICX104BICX104 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. |
| Vivitrol | Active comparator | Drug: VivitrolVivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent.
- Female or male subjects aged 18-50 years old.
- Without current non-remitted DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) - Substance Use Disorders diagnoses; subjects with a sustained remission diagnosis are not excluded.
- In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
- Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
Key exclusion criteria (15 listed)
- Is pregnant, is planning to become pregnant or breastfeed infants during the study.
- Is currently treated with naltrexone or has had a naltrexone implant in the past 2 years or received Vivitrol treatment in the past year.
- Clinically significant medical/psychological condition or abnormality at screening (i.e., physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings), including any diagnosis of Hepatitis B, Hepatitis C or HIV infection.
- Presence of opiates, cocaine, methamphetamine or other significant drugs of abuse in the urine (as determined by urine drug test).
- Any active hepatitis or hepatic failure or dysfunction evidenced by the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 1.5 times the upper limit of normal (1.5xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 2.5xULN, prolonged prothrombin time (international normalized ratio ≥1.7), ascites, or esophageal variceal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BICX104Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate. | Drug | BICX104 |
| VivitrolIntramuscular injection containing 380 mg of naltrexone. | Drug | Vivitrol |
Primary outcome
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.
1 secondary outcome
Safety Parameter: AEs
Time frame: 168 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BICX104 and Vivitrol in people with Opioid-use Disorder, run by BioCorRx Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter: Cmax. (time frame: 140 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.