Trial Outcomes & Findings for Pharmacokinetic Study of Vivitrol in Healthy Participants (NCT NCT04716881)
NCT ID: NCT04716881
Last Updated: 2024-02-23
Results Overview
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
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.
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Vivitrol (Naltrexone)
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Vivitrol (Naltrexone)
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Pharmacokinetic Study of Vivitrol in Healthy Participants
Baseline characteristics by cohort
| Measure |
Vivitrol (Naltrexone)
n=9 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Age, Continuous
|
50.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
25.90 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Cmax of Naltrexone (After 1st Dose)
|
14.10 ng/mL
Interval 13.4 to 23.1
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Tmax of Naltrexone (After 1st Dose)
|
2.00 day
Interval 1.96 to 3.02
|
PRIMARY outcome
Timeframe: 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.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
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median AUC0-inf of Naltrexone (After 1st Dose)
|
153.00 day*ng/mL
Interval 107.01 to 180.83
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Ctrough of Naltrexone (After 1st Dose)
|
0.81 ng/mL
Interval 0.49 to 1.06
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Cmax of 6β-naltrexol (After First Dose)
|
20.50 ng/mL
Interval 17.3 to 26.1
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Tmax of 6β-naltrexol (After 1st Dose)
|
3.02 day
Interval 2.0 to 3.15
|
PRIMARY outcome
Timeframe: 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.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
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median AUC0-inf of 6β-naltrexol (After 1st Dose)
|
270.16 day*ng/mL
Interval 216.32 to 342.38
|
PRIMARY outcome
Timeframe: 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.Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Ctrough of 6β-naltrexol (After 1st Dose)
|
1.71 ng/mL
Interval 1.33 to 1.97
|
PRIMARY outcome
Timeframe: 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 196PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Cmax of Naltrexone (After 6th Dose)
|
14.00 ng/mL
Interval 11.8 to 17.6
|
PRIMARY outcome
Timeframe: 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 196PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Tmax of Naltrexone (After 6th Dose)
|
2.00 day
Interval 1.97 to 2.94
|
PRIMARY outcome
Timeframe: 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 196PK 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
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median AUC0-inf of Naltrexone (After 6th Dose)
|
167.14 day*ng/mL
Interval 127.03 to 199.65
|
PRIMARY outcome
Timeframe: 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 196PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Ctrough of Naltrexone (After 6th Dose)
|
1.37 ng/mL
Interval 0.52 to 1.75
|
PRIMARY outcome
Timeframe: 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 196PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Cmax of 6β-naltrexol (After 6th Dose)
|
24.70 ng/mL
Interval 19.5 to 31.0
|
PRIMARY outcome
Timeframe: 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 196PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Tmax of 6β-naltrexol (After th Dose)
|
2.95 day
Interval 2.0 to 3.02
|
PRIMARY outcome
Timeframe: 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 196PK 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
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median AUC0-inf of 6β-naltrexol (After 6th Dose)
|
310.49 day*ng/mL
Interval 217.12 to 367.51
|
PRIMARY outcome
Timeframe: 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 196PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Median Ctrough of 6β-naltrexol (After 6th Dose)
|
2.02 ng/mL
Interval 1.45 to 3.5
|
SECONDARY outcome
Timeframe: Up to Day 196Proportion of participants reporting AEs
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=8 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Adverse Events (AEs)
|
4 Participants
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Naltrexone Accumulation Ratio (AR) for Cmax
|
0.96 ratio
Geometric Coefficient of Variation 49.16
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Naltrexone Accumulation Ratio (AR) for Ctrough
|
1.58 ratio
Geometric Coefficient of Variation 33.91
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
Naltrexone Accumulation Ratio (AR) for AUC0-inf
|
1.08 ratio
Geometric Coefficient of Variation 12.27
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
6β-naltrexol Accumulation Ratio (AR) for Cmax
|
1.08 ratio
Geometric Coefficient of Variation 0.63
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
6β-naltrexol Accumulation Ratio (AR) for Ctrough
|
1.37 ratio
Geometric Coefficient of Variation 34.53
|
SECONDARY outcome
Timeframe: 196 days after the 6th doseThe 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1.
Outcome measures
| Measure |
Vivitrol (Naltrexone)
n=7 Participants
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
6β-naltrexol Accumulation Ratio (AR) for AUC0-inf
|
1.14 ratio
Geometric Coefficient of Variation 7.43
|
Adverse Events
Vivitrol (Naltrexone)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vivitrol (Naltrexone)
n=8 participants at risk
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
|
|---|---|
|
General disorders
Injection site inflammation
|
12.5%
1/8 • Number of events 1 • 196 days
|
|
General disorders
Injection site pain
|
12.5%
1/8 • Number of events 2 • 196 days
|
|
Infections and infestations
Corona virus infection
|
12.5%
1/8 • Number of events 1 • 196 days
|
|
Injury, poisoning and procedural complications
Foot fracture
|
12.5%
1/8 • Number of events 1 • 196 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
12.5%
1/8 • Number of events 1 • 196 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • 196 days
|
|
Social circumstances
Aborted pregnancy
|
12.5%
1/8 • Number of events 1 • 196 days
|
Additional Information
Director of Operations
Go Medical Industries, Pty Ltd
Phone: 61(8) 9388 1700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60