Phase 1
Completed N=9
Pharmacokinetic Study of Vivitrol in Healthy Participants
Source: ClinicalTrials.gov NCT04716881 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Median Cmax of Naltrexone (After 1st Dose) — 14.10 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Cmax of Naltrexone (After 1st Dose) |
14.10 | — |
| PRIMARY Median Tmax of Naltrexone (After 1st Dose) |
2.00 | — |
| PRIMARY Median AUC0-inf of Naltrexone (After 1st Dose) |
153.00 | — |
| PRIMARY Median Ctrough of Naltrexone (After 1st Dose) |
0.81 | — |
| PRIMARY Median Cmax of 6β-naltrexol (After First Dose) |
20.50 | — |
| PRIMARY Median Tmax of 6β-naltrexol (After 1st Dose) |
3.02 | — |
| PRIMARY Median AUC0-inf of 6β-naltrexol (After 1st Dose) |
270.16 | — |
| PRIMARY Median Ctrough of 6β-naltrexol (After 1st Dose) |
1.71 | — |
| PRIMARY Median Cmax of Naltrexone (After 6th Dose) |
14.00 | — |
| PRIMARY Median Tmax of Naltrexone (After 6th Dose) |
2.00 | — |
| PRIMARY Median AUC0-inf of Naltrexone (After 6th Dose) |
167.14 | — |
| PRIMARY Median Ctrough of Naltrexone (After 6th Dose) |
1.37 | — |
| PRIMARY Median Cmax of 6β-naltrexol (After 6th Dose) |
24.70 | — |
| PRIMARY Median Tmax of 6β-naltrexol (After th Dose) |
2.95 | — |
| PRIMARY Median AUC0-inf of 6β-naltrexol (After 6th Dose) |
310.49 | — |
| PRIMARY Median Ctrough of 6β-naltrexol (After 6th Dose) |
2.02 | — |
| SECONDARY Adverse Events (AEs) |
4 | — |
| SECONDARY Naltrexone Accumulation Ratio (AR) for Cmax |
0.96 | — |
| SECONDARY Naltrexone Accumulation Ratio (AR) for Ctrough |
1.58 | — |
| SECONDARY Naltrexone Accumulation Ratio (AR) for AUC0-inf |
1.08 | — |
| SECONDARY 6β-naltrexol Accumulation Ratio (AR) for Cmax |
1.08 | — |
| SECONDARY 6β-naltrexol Accumulation Ratio (AR) for Ctrough |
1.37 | — |
| SECONDARY 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf |
1.14 | — |
Eligibility Criteria
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 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).
Data sourced from ClinicalTrials.gov (NCT04716881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.