NCT03810495

The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers

Completed Phase 1 Results posted Last updated 12 November 2024

What this trial tests

Phase 1 trial testing naltrexone implant in Opioid Use Disorder in 20 participants. Completed in 22 March 2021.

Timeline

11 April 2019

Primary endpoint
18 March 2021

22 March 2021

Quick facts

Lead sponsor	Go Medical Industries Pty Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	11 April 2019
Primary completion	18 March 2021
Estimated completion	22 March 2021
Sites	1 location across United States

Drugs / interventions tested

• naltrexone implant — full drug profile →

Conditions studied

• Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Go Medical Industries Pty Ltd — full company profile →

Who can join

Adults 18 to 55, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants That Maintain MEC Primary · up to 540 days or until NTX blood levels become undetectable

Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days

Group	Value	95% CI
OLANI (Naltrexone Implant)	10

Median Cmax of Naltrexone Secondary · 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

Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	17.00	5.38 – 71.4

Tmax of Naltrexone Secondary · 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

Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	49.63	0.47 – 268

AUC of Naltrexone Secondary · 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

Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	1440.5	991.1 – 2022

Median Cmax of 6β-naltrexol Secondary · 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

Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	23.45	10.2 – 126

Median Tmax of 6β-naltrexol Secondary · 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

Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	49.70	1 – 176.3

Time>Minimum Effective Concentration Secondary · 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 (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33

Group	Value	95% CI
OLANI (Naltrexone Implant)	270	56 – 360

AUC of 6β-naltrexol Secondary · 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

Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1

Group	Value	95% CI
OLANI (Naltrexone Implant)	2856.50	1484 – 4990

Incidence of Adverse Events (AEs) Secondary · Up to 540 days or until NTX blood levels become undetectable

Incidence and Severity of AEs

Participants with at least One Treatment-Emergent Adverse Event

Group	Value	95% CI
OLANI (Naltrexone Implant)	19

Implant site inflammation

Group	Value	95% CI
OLANI (Naltrexone Implant)	7

Vomiting

Group	Value	95% CI
OLANI (Naltrexone Implant)	7

Headache

Group	Value	95% CI
OLANI (Naltrexone Implant)	5

Implant site pruritus

Group	Value	95% CI
OLANI (Naltrexone Implant)	4

Nausea

Group	Value	95% CI
OLANI (Naltrexone Implant)	3

Diarrhoea

Group	Value	95% CI
OLANI (Naltrexone Implant)	3

Upper respiratory tract infection

Group	Value	95% CI
OLANI (Naltrexone Implant)	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OLANI (Naltrexone Implant)

Serious: 2/20 (10%)

Deaths: 0/20

Serious adverse events (2 terms)

Reaction	System	OLANI (Naltrexone Implant)
Stab Wound	Injury, poisoning and procedural complications	—
Vomiting	Gastrointestinal disorders	—

Other adverse events (37 terms — click to expand)

Reaction	System	OLANI (Naltrexone Implant)
Vomiting	Gastrointestinal disorders	—
Implant site inflammation	General disorders	—
Headache	Nervous system disorders	—
Implant site pruritus	General disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Upper respiratory tract infection	Infections and infestations	—
Implant site pain	General disorders	—
Weight increased	Investigations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Implant site reaction	General disorders	—
Feeling hot	General disorders	—
Pyrexia	General disorders	—
Hypersensitivity	Immune system disorders	—
Bacterial vaginosis	Infections and infestations	—
Corona virus infection	Infections and infestations	—
Diverticulitis	Infections and infestations	—
Gastroenteritis	Infections and infestations	—
Herpes zoster	Infections and infestations	—
Hordeolum	Infections and infestations	—
Influenza	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Clavicle fracture	Injury, poisoning and procedural complications	—
Eyelid injury	Injury, poisoning and procedural complications	—
Joint dislocation	Injury, poisoning and procedural complications	—
Procedural pain	Injury, poisoning and procedural complications	—
Road traffic accident	Injury, poisoning and procedural complications	—
Stab wound	Injury, poisoning and procedural complications	—
Decreased appetite	Metabolism and nutrition disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Exploratory operation	Surgical and medical procedures	—
Hot flush	Vascular disorders	—
Dysmenorrhoea	Reproductive system and breast disorders	—

Most-reported serious reactions: Stab Wound, Vomiting.

Data from ClinicalTrials.gov NCT03810495 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.