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CompletedNCT04716881Updated Feb 23, 2024Results posted

Pharmacokinetic Study of Vivitrol in Healthy Participants

A Phase 1 interventional study of Naltrexone 380 MG in Opioid-use Disorder, sponsored by Go Medical Industries Pty Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Go Medical Industries Pty Ltd · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 57 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Opioid-use Disorder

Keywords

  • naltrexone
  • opioids
  • Opioid Use Disorder
03

Who can participate

Ages eligible
18 Years to 57 Years
Sexes eligible
All
Accepts 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

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).
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Vivitrol (naltrexone)

    Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.

    Drug: Naltrexone 380 MG

Interventions

  • DrugNaltrexone 380 MG

    Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days

    Also known as: Vivitrol

05

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. Adverse Events (AEs)

    Proportion of participants reporting AEs

    Time frame: Up to Day 196

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

06

Results

Posted Jun 9, 2023

Participant flow

Participant flow — Overall Study
MilestoneVivitrol (Naltrexone)
Started9
Completed7
Not completed2
Withdrew: Adverse event1
Withdrew: Lost to follow-up1

Outcome measures

PrimaryMedian 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.
Reported as:
Median · ng/mL
Median Cmax of Naltrexone (After 1st Dose)
ng/mLVivitrol (Naltrexone)
Median Cmax of Naltrexone (After 1st Dose)14.10 (13.40 to 23.10)
PrimaryMedian 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.
Reported as:
Median · day
Median Tmax of Naltrexone (After 1st Dose)
dayVivitrol (Naltrexone)
Median Tmax of Naltrexone (After 1st Dose)2.00 (1.96 to 3.02)
PrimaryMedian 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.
Reported as:
Median · day*ng/mL
Median AUC0-inf of Naltrexone (After 1st Dose)
day*ng/mLVivitrol (Naltrexone)
Median AUC0-inf of Naltrexone (After 1st Dose)153.00 (107.01 to 180.83)
PrimaryMedian 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.
Reported as:
Median · ng/mL
Median Ctrough of Naltrexone (After 1st Dose)
ng/mLVivitrol (Naltrexone)
Median Ctrough of Naltrexone (After 1st Dose)0.81 (0.49 to 1.06)
PrimaryMedian 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.
Reported as:
Median · ng/mL
Median Cmax of 6β-naltrexol (After First Dose)
ng/mLVivitrol (Naltrexone)
Median Cmax of 6β-naltrexol (After First Dose)20.50 (17.30 to 26.10)
PrimaryMedian 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.
Reported as:
Median · day
Median Tmax of 6β-naltrexol (After 1st Dose)
dayVivitrol (Naltrexone)
Median Tmax of 6β-naltrexol (After 1st Dose)3.02 (2.00 to 3.15)
PrimaryMedian 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.
Reported as:
Median · day*ng/mL
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
day*ng/mLVivitrol (Naltrexone)
Median AUC0-inf of 6β-naltrexol (After 1st Dose)270.16 (216.32 to 342.38)
PrimaryMedian 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.
Reported as:
Median · ng/mL
Median Ctrough of 6β-naltrexol (After 1st Dose)
ng/mLVivitrol (Naltrexone)
Median Ctrough of 6β-naltrexol (After 1st Dose)1.71 (1.33 to 1.97)
PrimaryMedian 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
Reported as:
Median · ng/mL
Median Cmax of Naltrexone (After 6th Dose)
ng/mLVivitrol (Naltrexone)
Median Cmax of Naltrexone (After 6th Dose)14.00 (11.80 to 17.60)
PrimaryMedian 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
Reported as:
Median · day
Median Tmax of Naltrexone (After 6th Dose)
dayVivitrol (Naltrexone)
Median Tmax of Naltrexone (After 6th Dose)2.00 (1.97 to 2.94)
PrimaryMedian 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
Reported as:
Median · day*ng/mL
Median AUC0-inf of Naltrexone (After 6th Dose)
day*ng/mLVivitrol (Naltrexone)
Median AUC0-inf of Naltrexone (After 6th Dose)167.14 (127.03 to 199.65)
PrimaryMedian 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
Reported as:
Median · ng/mL
Median Ctrough of Naltrexone (After 6th Dose)
ng/mLVivitrol (Naltrexone)
Median Ctrough of Naltrexone (After 6th Dose)1.37 (0.52 to 1.75)
PrimaryMedian 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
Reported as:
Median · ng/mL
Median Cmax of 6β-naltrexol (After 6th Dose)
ng/mLVivitrol (Naltrexone)
Median Cmax of 6β-naltrexol (After 6th Dose)24.70 (19.50 to 31.00)
PrimaryMedian 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
Reported as:
Median · day
Median Tmax of 6β-naltrexol (After th Dose)
dayVivitrol (Naltrexone)
Median Tmax of 6β-naltrexol (After th Dose)2.95 (2.00 to 3.02)
PrimaryMedian 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
Reported as:
Median · day*ng/mL
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
day*ng/mLVivitrol (Naltrexone)
Median AUC0-inf of 6β-naltrexol (After 6th Dose)310.49 (217.12 to 367.51)
PrimaryMedian 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
Reported as:
Median · ng/mL
Median Ctrough of 6β-naltrexol (After 6th Dose)
ng/mLVivitrol (Naltrexone)
Median Ctrough of 6β-naltrexol (After 6th Dose)2.02 (1.45 to 3.50)
SecondaryAdverse Events (AEs)

Proportion of participants reporting AEs

Time frame:
Up to Day 196
Reported as:
Count of participants · Participants
Adverse Events (AEs)
ParticipantsVivitrol (Naltrexone)
Adverse Events (AEs)4
SecondaryNaltrexone 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
Reported as:
Geometric mean · ratio
Naltrexone Accumulation Ratio (AR) for Cmax
ratioVivitrol (Naltrexone)
Naltrexone Accumulation Ratio (AR) for Cmax0.96 ± 49.16
SecondaryNaltrexone 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
Reported as:
Geometric mean · ratio
Naltrexone Accumulation Ratio (AR) for Ctrough
ratioVivitrol (Naltrexone)
Naltrexone Accumulation Ratio (AR) for Ctrough1.58 ± 33.91
SecondaryNaltrexone 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
Reported as:
Geometric mean · ratio
Naltrexone Accumulation Ratio (AR) for AUC0-inf
ratioVivitrol (Naltrexone)
Naltrexone Accumulation Ratio (AR) for AUC0-inf1.08 ± 12.27
Secondary6β-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
Reported as:
Geometric mean · ratio
6β-naltrexol Accumulation Ratio (AR) for Cmax
ratioVivitrol (Naltrexone)
6β-naltrexol Accumulation Ratio (AR) for Cmax1.08 ± 0.63
Secondary6β-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
Reported as:
Geometric mean · ratio
6β-naltrexol Accumulation Ratio (AR) for Ctrough
ratioVivitrol (Naltrexone)
6β-naltrexol Accumulation Ratio (AR) for Ctrough1.37 ± 34.53
Secondary6β-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
Reported as:
Geometric mean · ratio
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
ratioVivitrol (Naltrexone)
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf1.14 ± 7.43

Adverse events

Collected over 196 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vivitrol (Naltrexone)0/8 (0%)0/8 (0%)4/8 (50%)
Most frequent other events
Most frequent other events
EventVivitrol (Naltrexone)
Injection site inflammationGeneral disorders1/8
Injection site painGeneral disorders1/8
Corona virus infectionInfections and infestations1/8
Foot fractureInjury, poisoning and procedural complications1/8
Humerus fractureInjury, poisoning and procedural complications1/8
UrticariaSkin and subcutaneous tissue disorders1/8
Aborted pregnancySocial circumstances1/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vivitrol (Naltrexone)
Median50.0 (40 to 55)
Sex: Female, Male
Sex: Female, Male(Participants)Vivitrol (Naltrexone)
Female5
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Vivitrol (Naltrexone)
Hispanic or Latino4
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Vivitrol (Naltrexone)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American4
White3
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Vivitrol (Naltrexone)
United States9
Body Mass Index (kg/m^2)
Body Mass Index (kg/m^2)(kg/m^2)Vivitrol (Naltrexone)
Median25.90 (22.8 to 29.9)
07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 25, 2021
  • Informed consent form · Dec 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04716881
Lead sponsor
Go Medical Industries Pty Ltd
Collaborators
National Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, Clinilabs, Inc.
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Jan 25, 2021
Primary completion
Apr 4, 2022
Completion
Apr 4, 2022
Results posted
Jun 9, 2023
Last update
Feb 23, 2024

Study contacts

Adam Bisaga, MD
principal investigator · New York State Psychiatric Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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