Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03715634 | Study of a Novel Subcutaneous Depot Formulation of Buprenorphine | PHASE1 | COMPLETED | 12 | — | — | Sep 20, 2017 | Jun 7, 2018 | Mar 4, 2019 | 1 | United Kingdom |
The key parameter of the time of maximum concentration (Tmax) of buprenorphine will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Depot buprenorphine (INDV-6200) | EXPERIMENTAL | Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive depot buprenorphine |
| Placebo | PLACEBO_COMPARATOR | Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive volume-matched placebo |
| Name | Type | Description |
|---|---|---|
| INDV-6200 | DRUG | Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo |
| Placebo | DRUG | Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo |
| SL Buprenorphine | DRUG | All subjects will receive SL buprenorphine as non-investigational IMP to confirm tolerability |
| Nalorex | DRUG | Both Periods will include series of nalorex administrations to antagonize potential opioid effects from buprenorphine |
Inclusion Criteria: 1. Healthy males or non-pregnant, non-lactating females 2. Body mass index of 18.0-33.0 kg/m2 or, if outside the range, considered not clinically significant by the Investigator 3. Willing and able to communicate and participate in the whole study 4. Provide written informed con...