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Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects

NCT07691372 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Wafermine™ (ketamine sublingual wafer)

Single-dose sublingual administration of Wafermine™ at dose levels of 25 mg, 50 mg, and 75 mg under fasting conditions.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • iX Biopharma Ltd.

    lead OTHER

Principal Investigators

  • Janakan Krishnarajah, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-09
Primary Completion
2026-07-17
Completion
2026-07-17
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691372 on ClinicalTrials.gov