Opioid-use DisorderPhase 1NCT04716881
Pharmacokinetic Study of Vivitrol in Healthy Participants
A Phase 1 study testing Naltrexone 380 MG in people with Opioid-use Disorder, run by Go Medical Industries Pty Ltd at 1 site in United States.
Trial summary
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Naltrexone 380 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 4 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have completed GM0017 (i.e. been administered OLANI (3.6 gram) and provided two consecutive monthly blood samples of NTX below 0.1 ng/mL)
- Men or women between ≥18 and <58 years old Without DSM 5 - Substance Related Disorders classification; in sustained remission is not exclusionary
- Able and willing to comply with the requirements of the protocol
- Able and willing to provide written informed consent
- Willing to undergo an injection of NTX to allow for investigational drug administration in the intramuscular tissue
- Have an initial weight between 45.3 and 81.6 kilograms (inclusive) or have a BMI inclusive of 18.5 to 30.0.
Who cannot join
- Is currently on active NTX medication.
- Positive UDS at screening for illicit substances.
- Has a condition which requires treatment with opioid based medication.
- Has a known hypersensitivity to NTX.
- Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema that is likely to impact the injection site area, or as determined by the evaluating physician.
- Demonstrates any abnormal skin tissue in the proposed injection area.
Show all 17Show fewer
- Is pregnant or planning to be. Women need to have negative pregnancy test at screening. Women need to agree to practice an effective method of contraception throughout participation.
- Participant is breastfeeding or planning to be.
- Has a current significant neurological (including cognitive and psychiatric disorders),
- Any clinically important abnormal finding as determined by medical history, physical examination, ECG or clinical laboratory tests.
- Any additional condition(s) that in the investigator's opinion would prohibit the participant from completing the study or would not be in the best interest of the participant.
- ALT or AST >3 times the upper end of the laboratory normal range.
- Any methadone use 14 days prior to screening, and up to Study Day 0.
- Current DSM 5 diagnosis of schizophrenia, bipolar, anxiety, or depressive disorder, confirmed by MINI assessment, or currently treated with medications for anxiety or depression. Past history (in remission DSM 5 classification) of anxiety or depression is not exclusionary.
- Any elevated risk for suicide measured using the Columbia Suicide Severity Rating Scale, endorsing any of the items in the past month (C-SSRS, Lifetime)
- Is participating or intending to participate in any other clinical trial during the duration of this study.
- Is allergic to any of the ingredients in Vivitrol or the diluent used to mix Vivitrol (i.e. carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Bioequivalence Study Comparing Vivitrol and O'Neil Long Acting Naltrexone Implant (OLANI) in Healthy Participants
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
Read the detailed description
This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).
This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur.
- Conditions
- Opioid-use Disorder
- Being tested
- Naltrexone 380 MG
- Keywords
- naltrexone, opioids, Opioid Use Disorder
- 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.
Naltrexone 380 MGDrug
Also called Vivitrol
Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Vivitrol (naltrexone) | Experimental | Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. Receives: Drug: Naltrexone 380 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Cmax of Naltrexone (After 1st Dose)
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Tmax of Naltrexone (After 1st Dose)
Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median AUC0-inf of Naltrexone (After 1st Dose)
Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Ctrough of Naltrexone (After 1st Dose)
Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Cmax of 6β-naltrexol (After First Dose)
Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Tmax of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Ctrough of 6β-naltrexol (After 1st Dose)
Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Measured: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Median Cmax of Naltrexone (After 6th Dose)
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Tmax of Naltrexone (After 6th Dose)
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median AUC0-inf of Naltrexone (After 6th Dose)
PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Ctrough of Naltrexone (After 6th Dose)
PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Cmax of 6β-naltrexol (After 6th Dose)
PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Tmax of 6β-naltrexol (After th Dose)
PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Median Ctrough of 6β-naltrexol (After 6th Dose)
PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Measured: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
Secondary outcomes (7)
Adverse Events (AEs)
Proportion of participants reporting AEs
Measured: Up to Day 196
Naltrexone Accumulation Ratio (AR) for Cmax
The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for Ctrough
The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for AUC0-inf
The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Cmax
The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Ctrough
The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Measured: 196 days after the 6th dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start25 Jan 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Go Medical Industries Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, Clinilabs, Inc.
- Responsible party
- Sponsor
- Investigators
- Adam Bisaga, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716881
- Sponsor's protocol ID
- GM0019
- Other IDs
- UG3DA047720, 406190
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2021
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study Comparing Vivitrol and O'Neil Long Acting Naltrexone Implant (OLANI) in Healthy Participants
- ClinicalTrials.gov ID
- NCT04716881
- Acronym / sponsor ID
- GM0019
- Conditions
- Opioid-use Disorder
- Keywords
- naltrexone, opioids, Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Go Medical Industries Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, Clinilabs, Inc.
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 9 Jun 2023
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 I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
Detailed description
This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).
This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivitrol (naltrexone) | Experimental | Drug: Naltrexone 380 MGIntramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have completed GM0017 (i.e. been administered OLANI (3.6 gram) and provided two consecutive monthly blood samples of NTX below 0.1 ng/mL)
- Men or women between ≥18 and <58 years old Without DSM 5 - Substance Related Disorders classification; in sustained remission is not exclusionary
- Able and willing to comply with the requirements of the protocol
- Able and willing to provide written informed consent
- Willing to undergo an injection of NTX to allow for investigational drug administration in the intramuscular tissue
Key exclusion criteria (17 listed)
- Is currently on active NTX medication.
- Positive UDS at screening for illicit substances.
- Has a condition which requires treatment with opioid based medication.
- Has a known hypersensitivity to NTX.
- Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema that is likely to impact the injection site area, or as determined by the evaluating physician.
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 |
|---|---|---|
| Naltrexone 380 MGAlso: VivitrolVivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days | Drug | Vivitrol (naltrexone) |
Primary outcome
Median Cmax of Naltrexone (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
Median Tmax of Naltrexone (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0
Median AUC0-inf of Naltrexone (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Median Ctrough of Naltrexone (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Median Cmax of 6β-naltrexol (After First Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0
Median Tmax of 6β-naltrexol (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0
Median Ctrough of 6β-naltrexol (After 1st Dose)
Time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.
Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Median Cmax of Naltrexone (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
Median Tmax of Naltrexone (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
Median AUC0-inf of Naltrexone (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Median Ctrough of Naltrexone (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Median Cmax of 6β-naltrexol (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
Median Tmax of 6β-naltrexol (After th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140
Median Ctrough of 6β-naltrexol (After 6th Dose)
Time frame: 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196
PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
7 secondary outcomes
Adverse Events (AEs)
Time frame: Up to Day 196
Naltrexone Accumulation Ratio (AR) for Cmax
Time frame: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for Ctrough
Time frame: 196 days after the 6th dose
Naltrexone Accumulation Ratio (AR) for AUC0-inf
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Cmax
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for Ctrough
Time frame: 196 days after the 6th dose
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
Time frame: 196 days after the 6th dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Adam Bisaga, MD principal investigator
New York State Psychiatric Institute
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 Naltrexone 380 MG in people with Opioid-use Disorder, run by Go Medical Industries Pty Ltd 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 6 inclusion and 17 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 23 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Cmax of Naltrexone (After 1st Dose) (time frame: 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.). The study lists 16 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 23 Feb 2024.