Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OTF 1 · 1 trial · 1 indication
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...
OTF 1 is an investigational oral thin film formulation of (S)-ketamine designed for sublingual administration. It is being developed by Johnson & Johnson and has been studied in healthy participants. The program is in Phase 1 clinical development, and no approved indication has been disclosed.
OTF 1 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has completed one Phase 1 clinical trial of the candidate in healthy volunteers.
OTF 1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no later-stage trials have been recorded. It is an investigational product and has not been approved by the FDA for any indication.
OTF 1 has been evaluated in a single completed Phase 1 trial, NCT04300621, titled A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants. The trial enrolled 16 healthy adults in Belgium and used a controlled, randomized design without double blinding.
OTF 1 is an oral thin film formulation of (S)-ketamine intended for sublingual administration. The active agent is (S)-ketamine, while OTF 1 refers specifically to the thin film dosage form developed by Johnson & Johnson. It is not a different drug molecule.
OTF 1 is administered as an oral thin film placed under the tongue for sublingual absorption. This dosage form was evaluated in a completed Phase 1 study of different oral thin film (S)-ketamine formulations in healthy participants, conducted in Belgium.