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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03996694 | Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo. | PHASE1 | COMPLETED | 19 | — | — | Jul 23, 2019 | Oct 27, 2019 | Feb 5, 2021 | 1 | United States |
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Belbuca 300 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 300 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment B: Belbuca 600 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 600 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment C: Belbuca 900 µg and oral placebo | EXPERIMENTAL | Subjects treated with Belbuca 900 µg and oral placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment D: Oxycodone 30 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment E: Oxycodone 60 mg and buccal placebo | ACTIVE_COMPARATOR | Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Treatment F: Oral Placebo and buccal placebo | PLACEBO_COMPARATOR | Subjects treated with oral placebo and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio. |
| Name | Type | Description |
|---|---|---|
| Belbuca 300 µg | DRUG | Belbuca 300 µg buccal film |
| Belbuca 600 µg | DRUG | Belbuca 600 µg buccal film |
| Belbuca 900 µg | DRUG | Belbuca 900 µg buccal film |
| Oxycodone 30 mg | DRUG | Oxycodone 30 mg capsule |
| Oxycodone 60 mg | DRUG | Oxycodone 60 mg capsule |
| Placebo | DRUG | placebo buccal film and oral placebo |
Inclusion Criteria: 1. Male or female subjects 18 to 55 years of age, inclusive. 2. Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any ...