Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Wafermine™ (ketamine sublingual wafer)
Wafermine · 1 trial · 1 indication
Maximum observed plasma concentration (Cmax) of ketamine and norketamine following administration of study treatment. Plasma concentrations will be derived using non-compartmental analysis (NCA).
Terminal elimination half-life (t½) of ketamine and norketamine calculated from the terminal phase of the plasma concentration-time curve using non-compartmental analysis.
Time to maximum observed plasma concentration (Tmax) of ketamine and norketamine following administration of study treatment.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC₀-t) and extrapolated to infinity (AUC∞) for ketamine and norketamine, calculated using non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Wafermine™ Sublingual Wafer | EXPERIMENTAL | Participants will receive single doses of Wafermine™ (25 mg, 50 mg and 75 mg) administered sublingually in three sequential treatment periods. |
| Name | Type | Description |
|---|---|---|
| Wafermine™ (ketamine sublingual wafer) | DRUG | Single-dose sublingual administration of Wafermine™ at dose levels of 25 mg, 50 mg, and 75 mg under fasting conditions. |
Inclusion Criteria 1. Clinically healthy participants (male and female) aged ≥ 18 to ≤ 65 years at the time of signing the informed consent. 2. Research participants with no history of clinically significant cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, uro...
Wafermine is an investigational ketamine sublingual wafer being studied in healthy adult participants. It is currently in Phase 1 clinical development, with a single trial evaluating its pharmacokinetics and safety. The drug is not approved and remains under investigation.
Wafermine is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker UTHR. The company is conducting a Phase 1 clinical trial of this investigational ketamine sublingual wafer.
Wafermine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the pharmacokinetics and safety of a single dose in healthy subjects.
Wafermine is being studied in one Phase 1 clinical trial, identified as NCT07691372. This trial, titled 'Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects,' is not yet recruiting and is planned to enroll 14 participants in Australia.
Wafermine is a ketamine sublingual wafer, meaning it is a formulation of ketamine designed to be administered under the tongue. It is an investigational product being developed by United Therapeutics Corporation and is currently in Phase 1 clinical trials.