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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04300621 | A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Jun 19, 2020 | Aug 10, 2020 | Apr 27, 2025 | 1 | Belgium |
Maximum plasma concentration will be reported.
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported.
Area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda, in which C(last) is the last observed quantifiable concentrations will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1: OTF 1, 4, 2, 3 | EXPERIMENTAL | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 1 in period 1; followed by OTF 4 in period 2; followed by OTF 2 in period 3; followed by OTF 3 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
| Treatment Sequence 2: OTF 2, 1, 3, 4 | EXPERIMENTAL | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 2 in period 1; followed by OTF 1 in period 2; followed by OTF 3 in period 3; followed by OTF 4 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
| Treatment Sequence 3: OTF 3, 2, 4, 1 | EXPERIMENTAL | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 3 in period 1; followed by OTF 2 in period 2; followed by OTF 4 in period 3; followed by OTF 1 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
| Treatment Sequence 4: OTF 4, 3, 1, 2 | EXPERIMENTAL | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 4 in period 1; followed by OTF 3 in period 2; followed by OTF 1 in period 3; followed by OTF 2 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| OTF 1 | DRUG | Participants will receive (S)-ketamine administered sublingually through OTF 1. |
| OTF 2 | DRUG | Participants will receive (S)-ketamine administered sublingually through OTF 2. |
| OTF 3 | DRUG | Participants will receive (S)-ketamine administered sublingually through OTF 3. |
| OTF 4 | DRUG | Participants will receive (S)-ketamine administered sublingually through OTF 4. |
Inclusion Criteria: * Body Mass Index (BMI) between 20.0 and 28.0 kilogram per square meters (kg/m\^2) inclusive (BMI=weight/height\^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg * Participant must be healthy based on clinical laboratory tests performed at screening. If the r...