Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIOPIN-6 Active with Naltrexone · 1 trial · 1 indication
Area under the plasma naltrexone concentration-time curve (AUC) from implant placement through Day 98, calculated using noncompartmental pharmacokinetic methods based on serial plasma concentration measurements. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Naltrexone Peak Plasma Concentration (Cmax) \[ng/ml\]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Time to maximum observed plasma concentration (Tmax) of naltrexone following implant placement.
Area under the plasma concentration-time curve (AUC) of 6-β-naltrexol from implant placement through Day 98. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Maximum observed plasma concentration (Cmax) of 6-β-naltrexol following implant placement.\[ng/ml\]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.
Time to maximum observed plasma concentration (Tmax) of 6-β-naltrexol following implant placement.
| Arm | Type | Description |
|---|---|---|
| BIOPIN-6 active implant | EXPERIMENTAL | Two sequential cohorts receiving 4.8 or 9.6 BIOPIN 6 implanted into a subcutaneous pocket in the upper abdominal wall. |
| BIOPIN-6 placebo implant | PLACEBO_COMPARATOR | The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone. |
| Name | Type | Description |
|---|---|---|
| BIOPIN-6 Active Implant with Naltrexone | COMBINATION_PRODUCT | An extended release formulation of naltrexone implanted in the subcutaneous space. |
| BIOPIN-6 Placebo Implant | DEVICE | The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone. |
Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: * Healthy male or female volunteer, aged 18-to-55 years, inclusive. * BMI must be between 18 and 32 kg/m2 (inclusive) and weigh a minimum of 50 kg (110 lbs). * If female, be postmenopausal (at least 2...