Opioid-use Disorder
Conditions
Keywords
naltrexone, opioids, Opioid Use Disorder
Brief 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.
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.
Interventions
Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Columbia University
Clinilabs, Inc.
Go Medical Industries Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 57 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Ctrough of 6β-naltrexol (After 6th Dose) | 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 |
| Median Cmax of Naltrexone (After 6th Dose) | 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) | 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) | 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) | 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) | 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) | 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) | 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 Cmax of Naltrexone (After 1st Dose) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Naltrexone Accumulation Ratio (AR) for Cmax | 196 days after the 6th dose | The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| Naltrexone Accumulation Ratio (AR) for Ctrough | 196 days after the 6th dose | The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| Naltrexone Accumulation Ratio (AR) for AUC0-inf | 196 days after the 6th dose | The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| 6β-naltrexol Accumulation Ratio (AR) for Cmax | 196 days after the 6th dose | The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| 6β-naltrexol Accumulation Ratio (AR) for Ctrough | 196 days after the 6th dose | The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf | 196 days after the 6th dose | The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
| Adverse Events (AEs) | Up to Day 196 | Proportion of participants reporting AEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vivitrol (Naltrexone) Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Vivitrol (Naltrexone) |
|---|---|
| Age, Continuous | 50.0 years |
| Body Mass Index (kg/m^2) | 25.90 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 4 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median AUC0-inf of 6β-naltrexol (After 1st Dose) | 270.16 day*ng/mL |
Primary
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median AUC0-inf of 6β-naltrexol (After 6th Dose) | 310.49 day*ng/mL |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median AUC0-inf of Naltrexone (After 1st Dose) | 153.00 day*ng/mL |
Primary
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median AUC0-inf of Naltrexone (After 6th Dose) | 167.14 day*ng/mL |
Primary
Median Cmax of 6β-naltrexol (After 6th Dose)
PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Cmax of 6β-naltrexol (After 6th Dose) | 24.70 ng/mL |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Cmax of 6β-naltrexol (After First Dose) | 20.50 ng/mL |
Primary
Median Cmax of Naltrexone (After 1st Dose)
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Cmax of Naltrexone (After 1st Dose) | 14.10 ng/mL |
Primary
Median Cmax of Naltrexone (After 6th Dose)
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Cmax of Naltrexone (After 6th Dose) | 14.00 ng/mL |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Ctrough of 6β-naltrexol (After 1st Dose) | 1.71 ng/mL |
Primary
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Ctrough of 6β-naltrexol (After 6th Dose) | 2.02 ng/mL |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Ctrough of Naltrexone (After 1st Dose) | 0.81 ng/mL |
Primary
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Ctrough of Naltrexone (After 6th Dose) | 1.37 ng/mL |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Tmax of 6β-naltrexol (After 1st Dose) | 3.02 day |
Primary
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
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Tmax of 6β-naltrexol (After th Dose) | 2.95 day |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Tmax of Naltrexone (After 1st Dose) | 2.00 day |
Primary
Median Tmax of Naltrexone (After 6th Dose)
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vivitrol (Naltrexone) | Median Tmax of Naltrexone (After 6th Dose) | 2.00 day |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf | 1.14 ratio | Geometric Coefficient of Variation 7.43 |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | 6β-naltrexol Accumulation Ratio (AR) for Cmax | 1.08 ratio | Geometric Coefficient of Variation 0.63 |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | 6β-naltrexol Accumulation Ratio (AR) for Ctrough | 1.37 ratio | Geometric Coefficient of Variation 34.53 |
Secondary
Adverse Events (AEs)
Proportion of participants reporting AEs
Time frame: Up to Day 196
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vivitrol (Naltrexone) | Adverse Events (AEs) | 4 Participants |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | Naltrexone Accumulation Ratio (AR) for AUC0-inf | 1.08 ratio | Geometric Coefficient of Variation 12.27 |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | Naltrexone Accumulation Ratio (AR) for Cmax | 0.96 ratio | Geometric Coefficient of Variation 49.16 |
Secondary
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.
Time frame: 196 days after the 6th dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Vivitrol (Naltrexone) | Naltrexone Accumulation Ratio (AR) for Ctrough | 1.58 ratio | Geometric Coefficient of Variation 33.91 |