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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA047720 | U.S. NIH Grant/Contract | View source | |
| 240358 | Other Identifier | NIH ERA Human Subjects Study Number |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| New York State Psychiatric Institute | OTHER |
| Columbia University | OTHER |
| Clinilabs, Inc. |
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This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
Naltrexone (NTX) is a nonspecific pure opioid antagonist with a high affinity for the µ-opioid receptor. It blocks the effects of opioids by competitive binding at opiate receptors. NTX is used primarily in the management of opiate and alcohol dependence. It is available in the United States (US) as 2 formulations; a once daily oral formulation (Revia) and a once monthly intramuscular injection (Vivitrol). While NTX is a potent antagonist and efficiently blocks the effects of exogenous opiates such as heroin, the success of NTX for the treatment of opiate dependence has been limited by poor patient compliance. Therefore, the development of a sustained release NTX formulation (in excess of 1 month) would be of great benefit for the treatment of opioid use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLANI (naltrexone implant) | Experimental | 2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naltrexone implant | Drug | 1.8 g implant containing 60% naltrexone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Maintain MEC | Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days | up to 540 days or until NTX blood levels become undetectable |
| Measure | Description | Time Frame |
|---|---|---|
| Median Cmax of Naltrexone | Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bisaga, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | OLANI (Naltrexone Implant) | 2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously naltrexone implant: 1.8 g implant containing 60% naltrexone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OLANI (Naltrexone Implant) | 2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously naltrexone implant: 1.8 g implant containing 60% naltrexone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants That Maintain MEC | Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Count of Participants | Participants | up to 540 days or until NTX blood levels become undetectable |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OLANI (Naltrexone Implant) | 2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously naltrexone implant: 1.8 g implant containing 60% naltrexone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stab Wound | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment | Multiple severe stab wounds to the iliac crest, mid-thorax and shoulder blade |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
This is a pilot study with a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Operations | Go Medical Industries, Pty Ltd | 61(8) 9388 1700 | ctc@gomedical.com.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 | Jul 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2019 | Jul 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| OTHER |
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| Tmax of Naltrexone | Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| AUC of Naltrexone | Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| Median Cmax of 6β-naltrexol | Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| Median Tmax of 6β-naltrexol | Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| Time>Minimum Effective Concentration | Time (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| AUC of 6β-naltrexol | Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1 | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
| Incidence of Adverse Events (AEs) | Incidence and Severity of AEs | Up to 540 days or until NTX blood levels become undetectable |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Median Cmax of Naltrexone | Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | ng/mL | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | Tmax of Naltrexone | Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | day | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | AUC of Naltrexone | Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | day*ng/mL | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | Median Cmax of 6β-naltrexol | Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | ng/mL | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | Median Tmax of 6β-naltrexol | Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | day | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | Time>Minimum Effective Concentration | Time (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | days | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | AUC of 6β-naltrexol | Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1 | Per-Protocol Population consisted of all subjects who completed at least 75% valid PK blood samples including 2 consecutive undetectable values (defined as <0.1 ng/mL) and those without any major protocol deviations. | Posted | Median | Full Range | day*ng/mL | pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days |
|
|
|
| Secondary | Incidence of Adverse Events (AEs) | Incidence and Severity of AEs | Posted | Number | participants | Up to 540 days or until NTX blood levels become undetectable |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 19 |
| 20 |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment | Cannabinoid hyperemesis syndrome |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Implant site inflammation | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Implant site pruritus | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Implant site pain | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Implant site reaction | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Stab wound | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Exploratory operation | Surgical and medical procedures | MedDRA (21.0) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (21.0) | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Headache |
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| Implant site pruritus |
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| Nausea |
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| Diarrhoea |
|
| Upper respiratory tract infection |
|
| Implant site pain |
|
| Back pain |
|
| Weight increased |
|