Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subj… (NCT07691372) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects
Australia14 participantsStarted 2026-06-09
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinically healthy participants (male and female) aged ≥ 18 to ≤ 65 years at the time of signing the informed consent.
. Research participants with no history of clinically significant cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, or renal diseases or comorbidity of significance at the discretion of the Principal Investigator (or his/her delegate). The following medical history are permitted at the discretion of the Principal Investigator: history of childhood asthma; prior history of cholecystectomy; history of eczema with no use of steroid creams for 3 months prior to screening; history of fully resolved gestational diabetes; current or history of ADHD, anxiety or antidepression ( stable condition with no use of antidepressants 6 months prior to screening)
. Be able and willing to read, understand, sign, and date the Informed Consent Form prior to entering the study.
. Have adequate venous access for blood sampling.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Plasma Concentration (Cmax) of Ketamine and Norketamine
Timeframe: From pre-dose through the last measurable concentration, with plasma samples collected up to 36 hours post-dose.
2
Terminal Elimination Half-Life (t½) of Ketamine and Norketamine
Timeframe: From pre-dose through the last measurable concentration, with plasma samples collected up to 36 hours post-dose.
3
Time to Peak Plasma Concentration (Tmax) of Ketamine and Norketamine
Timeframe: Pre-dose to 36 hours post-dose
4
Area Under the Plasma Concentration-Time Curve (AUC) of Ketamine and Norketamine
Timeframe: From pre-dose through the last measurable concentration, with plasma samples collected up to 36 hours post-dose.
. Female participants are eligible only if all the following contraceptive requirements are met:
. Male contraceptive Requirements These requirements also apply to sperm donation;
. Body mass index between 18.5-30.0kg/m2 (inclusive) index.
. Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
Exclusion criteria
. Research participants with inflammatory or ulcerative disease in the oral cavity that may affect the absorption of the sublingual presentation.
. History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his or her delegate, is likely to be exacerbated by the study drug.
. History of hypersensitivity to ketamine or any of the WafermineTM excipients.
. Elective procedures or surgeries scheduled after signing the Informed Consent Form and until the safety follow-up call \[3 days ± 1 day after the 36.0-hour third period is taken\].
. History of gastric bypass surgery/bariatric surgery or other gastrointestinal surgery or condition that may affect gastric emptying or absorption of the study drug.
. A history of 6 previous months of psychiatric disorders (schizophrenia, anxiety, acute psychosis, depression). A clinically significant history of psychiatric disorders (including but not limited to: schizophrenia, anxiety, acute psychosis, depression). Resolved psychiatric disorders (\>6 months before screening) may be included at the discretion of the Investigator or delegate).
. Positive serology for hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
. Presence of chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) at the discretion of the Principal Investigator, within 90 days prior to the screening visit and between the screening visit and Day -1.