Trial Outcomes & Findings for The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers (NCT NCT03810495)
NCT ID: NCT03810495
Last Updated: 2024-11-12
Results Overview
Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days
COMPLETED
PHASE1
20 participants
up to 540 days or until NTX blood levels become undetectable
2024-11-12
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
OLANI (Naltrexone Implant)
n=20 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
24.92 kg/m^2
STANDARD_DEVIATION 3.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 540 days or until NTX blood levels become undetectablePopulation: 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.
Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Percentage of Participants That Maintain MEC
|
10 Participants
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose pharmacokinetic (PK) measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Median Cmax of Naltrexone
|
17.00 ng/mL
Interval 5.38 to 71.4
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose PK measurement of the time to reach the maximum (Tmax) naltrexone concentration after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Tmax of Naltrexone
|
49.63 day
Interval 0.47 to 268.0
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose PK measurement of the area under the curve (AUC) for naltrexone after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
AUC of Naltrexone
|
1440.5 day*ng/mL
Interval 991.1 to 2022.0
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose PK measurement of the peak plasma 6β-naltrexol concentration after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Median Cmax of 6β-naltrexol
|
23.45 ng/mL
Interval 10.2 to 126.0
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose PK measurement of the time to reach the maximum 6β-naltrexol concentration after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Median Tmax of 6β-naltrexol
|
49.70 day
Interval 1.0 to 176.3
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Time (T) naltrexone remains above the minimum effective concentration (MEC) of 1.33
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Time>Minimum Effective Concentration
|
270 days
Interval 56.0 to 360.0
|
SECONDARY outcome
Timeframe: 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 daysPopulation: 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.
Single-dose PK measurement of the AUC for 6β-naltrexol concentration after dosing on Day 1
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=18 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
AUC of 6β-naltrexol
|
2856.50 day*ng/mL
Interval 1484.0 to 4990.0
|
SECONDARY outcome
Timeframe: Up to 540 days or until NTX blood levels become undetectableIncidence and Severity of AEs
Outcome measures
| Measure |
OLANI (Naltrexone Implant)
n=20 Participants
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Incidence of Adverse Events (AEs)
Participants with at least One Treatment-Emergent Adverse Event
|
19 participants
|
|
Incidence of Adverse Events (AEs)
Implant site inflammation
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Vomiting
|
7 participants
|
|
Incidence of Adverse Events (AEs)
Headache
|
5 participants
|
|
Incidence of Adverse Events (AEs)
Implant site pruritus
|
4 participants
|
|
Incidence of Adverse Events (AEs)
Nausea
|
3 participants
|
|
Incidence of Adverse Events (AEs)
Diarrhoea
|
3 participants
|
|
Incidence of Adverse Events (AEs)
Implant site pain
|
2 participants
|
|
Incidence of Adverse Events (AEs)
Back pain
|
2 participants
|
|
Incidence of Adverse Events (AEs)
Weight increased
|
2 participants
|
|
Incidence of Adverse Events (AEs)
Upper respiratory tract infection
|
3 participants
|
Adverse Events
OLANI (Naltrexone Implant)
Serious adverse events
| Measure |
OLANI (Naltrexone Implant)
n=20 participants at risk
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Injury, poisoning and procedural complications
Stab Wound
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
OLANI (Naltrexone Implant)
n=20 participants at risk
2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously
naltrexone implant: 1.8 g implant containing 60% naltrexone
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Number of events 3 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Number of events 3 • 18 months
|
|
General disorders
Implant site inflammation
|
35.0%
7/20 • Number of events 7 • 18 months
|
|
General disorders
Implant site pruritus
|
20.0%
4/20 • Number of events 4 • 18 months
|
|
General disorders
Implant site pain
|
10.0%
2/20 • Number of events 2 • 18 months
|
|
General disorders
Implant site reaction
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
General disorders
Feeling hot
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Immune system disorders
Hypersensitivity
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20 • Number of events 3 • 18 months
|
|
Infections and infestations
Bacterial vaginosis
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Corona virus infection
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Diverticulitis
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Injury, poisoning and procedural complications
Stab wound
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Investigations
Weight increased
|
10.0%
2/20 • Number of events 2 • 18 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • Number of events 5 • 18 months
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Exploratory operation
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Vascular disorders
Hot flush
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • Number of events 7 • 18 months
|
Additional Information
Director of Operations
Go Medical Industries, Pty Ltd
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
- Publication restrictions are in place
Restriction type: OTHER