Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Median Cmax of Naltrexone (After 1st Dose) |
Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0 |
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. |
|
Primary |
Median Tmax of Naltrexone (After 1st Dose) |
Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0 |
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. |
|
Primary |
Median AUC0-inf of Naltrexone (After 1st Dose) |
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 |
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. |
|
Primary |
Median Ctrough of Naltrexone (After 1st Dose) |
Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 |
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. |
|
Primary |
Median Cmax of 6ß-naltrexol (After First Dose) |
Single-dose PK measurement of the maximum observed plasma 6ß-naltrexol concentration (Cmax) after dosing on Day 0 |
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. |
|
Primary |
Median Tmax of 6ß-naltrexol (After 1st Dose) |
Single-dose PK measurement of the time to maximum plasma 6ß-naltrexol concentration (Tmax) after dosing on Day 0 |
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. |
|
Primary |
Median AUC0-inf of 6ß-naltrexol (After 1st Dose) |
Single-dose PK measurement of the area under the plasma concentration-time curve for 6ß-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0 |
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. |
|
Primary |
Median Ctrough of 6ß-naltrexol (After 1st Dose) |
Single-dose PK measurement of 6ß-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 |
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. |
|
Primary |
Median Cmax of Naltrexone (After 6th Dose) |
PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140 |
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 196 |
|
Primary |
Median Tmax of Naltrexone (After 6th Dose) |
PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140 |
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 196 |
|
Primary |
Median AUC0-inf of Naltrexone (After 6th 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 140 |
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 196 |
|
Primary |
Median Ctrough of Naltrexone (After 6th Dose) |
PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 |
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 196 |
|
Primary |
Median Cmax of 6ß-naltrexol (After 6th Dose) |
PK measurement of the maximum observed plasma 6ß-naltrexol concentration (Cmax) after dosing on Day 140 |
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 196 |
|
Primary |
Median Tmax of 6ß-naltrexol (After th Dose) |
PK measurement of the time to maximum plasma 6ß-naltrexol concentration (Tmax) after dosing on Day 140 |
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 196 |
|
Primary |
Median AUC0-inf of 6ß-naltrexol (After 6th Dose) |
PK measurement of the area under the plasma concentration-time curve for 6ß-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140 |
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 196 |
|
Primary |
Median Ctrough of 6ß-naltrexol (After 6th Dose) |
PK measurement of 6ß-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 |
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 196 |
|
Secondary |
Adverse Events (AEs) |
Proportion of participants reporting AEs |
Up to Day 196 |
|
Secondary |
Naltrexone Accumulation Ratio (AR) for Cmax |
The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|
Secondary |
Naltrexone Accumulation Ratio (AR) for Ctrough |
The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|
Secondary |
Naltrexone Accumulation Ratio (AR) for AUC0-inf |
The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|
Secondary |
6ß-naltrexol Accumulation Ratio (AR) for Cmax |
The 6ß-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|
Secondary |
6ß-naltrexol Accumulation Ratio (AR) for Ctrough |
The 6ß-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|
Secondary |
6ß-naltrexol Accumulation Ratio (AR) for AUC0-inf |
The 6ß-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
196 days after the 6th dose |
|