Clinical TrialKetamineRecruiting

A randomised open-label crossover study to investigate the safety, tolerability, pharmacokinetics, relative bioavailability, and pharmacodynamics of single doses of Katamine immediate release (KET-IR) and Ketamine abuse deterrent (KET-AD) oral ketamine capsules in healthy volunteers.

This open-label crossover Phase I trial (n=12) evaluated the safety and efficacy of ketamine for bipolar disorder.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

This phase I study aims to recruit healthy volunteers. Participants will be enrolled in 2 groups of 6 each (3 men and 3 woman). Each participant will attend 2 treatment sessions and receive two different formulations of Keticap®. In Period 1, Participants will be randomised to receive either a single dose of KET-IR (160 mg) or single dose of KET-AD (160 mg) in the first study session. Following at least 7 days wash-out period the participants will receive the alternate formulation to the one received in period 1second formulation in the final study session.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • 1. Male and female healthy volunteers.
  • 2. Aged 18–55 years.
  • 3. Non-smokers
  • 4. A body mass index (BMI); Quetelet index) in the range 18.0–30 kg/m2.
  • 5. Able to understand the nature of the trial and any hazards of participating in it.
  • 6. Willingness to give written consent to participate after reading the information and consent form
  • 7. Agree to follow the contraception requirements of the trial.
  • 8. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
  • 9. Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

Exclusion Criteria

  • 1. Clinically significant (in the opinion of the PI or delegate) medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
  • 2. Presence of an anxiety disorder, bipolar disorder or depression (moderate to severe) and psychosis as determined using a structured clinical Mini-International Neuropsychiatric Interview (MINI).
  • 3. First degree relative with psychosis (through self-report).
  • 4. Presence of clinically significant acute or chronic illness or history of chronic illness, as determined by the PI or delegate.
  • 5. History of clinically significant (in the opinion of the PI or delegate) endocrine, thyroid, hepatic, respiratory or renal disease.
  • 6. Diabetes mellitus, coronary heart disease, or history of any neurological condition (including migraines) or mental illness (prior DSM-5 diagnosis of a psychotic disorder or Major Depressive Disorder (MDD) with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder). Resolved anxiety and depression may be permitted at the discretion of the PI/delegate.
  • 7. Surgery (e.g. stomach bypass) or medical condition that might affect absorption of medicines. Cholecystectomy is exclusionary if the PI/delegate deems the participant to be of high-risk of malabsorption. Gilbert’s syndrome is permitted at the discretion of the PI/delegate.
  • 8. Presence or history of severe adverse reaction to any drug or a known hypersensitivity to Ketamine, or any component of the KET-IR and KET-AD formulations (lactose, Kelcogel, PEG 1500, Gelucire, gelatin, HPMC).
  • 9. Use of a prescription medicine during the 30 days before the first dose of trial medication, or use of an over-the-counter medicine (excluding herbal supplements and vitamins), with the exception of acetaminophen (paracetamol) and hormonal contraceptive medications, during the 7 days before the first dose of trial medication.
  • 10. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before first admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
  • 11. Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly (for men) or more than 14 units of alcohol weekly (for women), where 1.1 unit equals 285 mL of full-strength beer; 0.9 unit equals 425mL low-strength beer; 1 unit equals 100 mL of wine or 30 mL of spirits.
  • 12. Positive cotinine test at check-in. Positive urine drug screen or alcohol breath test at Screening or check-in.
  • 13. Has a history of suicide attempt(s) or suicidal ideation as indicated by the C-SSRS.
  • 14. Mean blood pressure and mean heart rate in supine position outside the ranges: blood pressure 90–140 mm Hg systolic, 40–90 mm Hg diastolic; heart rate 40–100 beats/min. Mean pulse oximetry SpO2 less than or equal to 90%. Repeats permitted at PI/delegate discretion.
  • 15. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) greater than or equal to 1.5 x upper limit of normal (ULN) at screening. A repeat is allowed on one occasion for determination of eligibility.
  • 16. Possibility that the volunteer will not cooperate with the requirements of the protocol.
  • 17. Positive test for hepatitis B, hepatitis C or HIV, or pregnancy.
  • 18. Loss of more than 400 mL blood during the 3 months before the Screening visit, e.g. as a blood donor.
  • 19. Vegetarians or vegans who are not willing to take a medicine that includes gelatine of animal origin.
  • 20. No food or drink containing grapefruit will be allowed from 7 days before dosing until the end of the trial
  • 21. No alcoholic drinks or smoking will be allowed during the period from midnight the day before admission until the end of each period of residence
  • 22. No strenuous exercise will be allowed from 3 days before admission until the end of each period of residence, and for 3 days before each outpatient visit
  • 23. Participants must not sunbathe or use a sunbed during the study
  • 24. Unwilling to abide by the study restrictions .
  • 25. Any other reason, in the opinion of PI or delegate, deeming the volunteer unsuitable for trial participation.

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2025-09-29
  • Compound
    Ketamine

Locations

Unknown facility — Australia

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