drugset / Trial / NCT07691372
Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects
Phase 1
Not yet recruiting
14 enrolled
iX Biopharma Ltd.
United States Department of Defense · collab
NaCrossoverOpen-labelTreatment
Summary
This is a Phase 1, open-label, three-period crossover study evaluating the pharmacokinetics and safety of single-dose Wafermine™ (ketamine sublingual wafer) at dose levels of 25 mg, 50 mg, and 75 mg in healthy adult participants under fasting conditions. Participants will receive all three dose levels in a fixed ascending sequence during a single inpatient admission, with washout periods between doses. Pharmacokinetic sampling will be conducted over 36 hours following each dose.
Timeline
- Start
- 2026-06-09
- Primary completion
- 2026-07-17
- Completion
- 2026-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 25 mg | Other |
| Subject | Ketamine | Small molecule | 50 mg | Other |
| Subject | Ketamine | Small molecule | 75 mg | Other |
Indications
No indication recorded.