Clinical TrialHealthy VolunteersKetamineKetamineNot yet recruiting

A study comparing two formulations of R-107 under fasting conditions

Phase I randomised, blinded crossover PK/bioavailability study (n=34) comparing R-107-H (3×60 mg) versus R-107-P (3×60 mg) in healthy volunteers under fasting conditions.

Target Enrollment
34 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Randomised, blinded, two-period crossover in healthy volunteers to compare bioavailability (AUC0-t, Cmax) of two extended-release ketamine formulations given as a single oral dose (3 × 60 mg = 180 mg) under fasting conditions.

Study duration ≈6 weeks including screening; each treatment period spans 3 days with dosing on Day 1 and intensive PK sampling (urine and plasma) including pre-dose and multiple post-dose windows up to 48 hours; minimum 1-week washout between periods.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

R-107-H (test)

experimental

Single oral dose of R-107-H ER (3 × 60 mg tablets) in a crossover period.

Interventions

  • Ketamine180 mg
    via Oral• single dose• 1 doses total

    3 × 60 mg R-107-H ER tablets with 240 ml water; tablets swallowed whole; mouth check to confirm ingestion.

R-107-P (reference)

active comparator

Single oral dose of innovator R-107-P ER (3 × 60 mg tablets) in crossover period.

Interventions

  • Ketamine180 mg
    via Oral• single dose• 1 doses total

    3 × 60 mg R-107-P ER tablets with 240 ml water; reference comparator for bioavailability.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Healthy males and non-pregnant female volunteers.
  • Aged between 18 and 55 on day of consent
  • Non-smoker
  • Drug free as determined by a Urine Drugs Test
  • BMI between 18.5 and 33.0
  • Normal, healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests
  • Able to provide written informed consent in English
  • Able to adhere to all study restrictions and attend all study visits
  • Consent to GP being contacted if necessary

Exclusion Criteria

  • Known history or presence of any clinically significant medical conditions
  • Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results as determined by the Investigator.
  • Positive test result for hepatitis B, hepatitis C, or HIV
  • A known allergy, hypersensitivity, or intolerance to ketamine, or other forms of ketamine, or its excipients.
  • History of significant alcohol abuse within one year prior to date of consent or regular use of alcohol within six months prior to the date of consent
  • History of significant drug abuse or dependency including ketamine or its excipients within one year prior to date of consent.
  • Use of Class A, B and C drugs as classified in the Misuse of Drugs Act 1975 within 3 months prior to the date of consent.
  • Significant current risk of suicide:
  • As assessed by C-SSRS, or
  • as assessed by the evaluating Trial Physician
  • Participation in a clinical research study within 60 days prior to Study Day 1
  • Use of medication other than topical products without significant systemic absorption.
  • Receiving treatment with monoamine oxidase inhibitors, vasoconstriction agents, thyroxine or benzodiazepines;
  • Prescription medication (except prescribed hormonal contraceptive) within 14 days prior to Study Day 1;
  • Over-the-counter products and natural health products within 7 days prior to Study Day 1, with the exception of the occasional use of paracetamol (up to 2 g daily);
  • Use of any enzyme-modifying drugs and/or other products in the previous 30 days before first study drug administration
  • Donation of platelets or plasma within 30 days prior to Study Day 1.
  • Participants of child-bearing potential who are pregnant, lactating or breastfeeding.
  • Participants of childbearing potential who are sexually active and are not using effective contraception for the prevention of pregnancy (i.e. prescribed hormonal contraceptives or other reliable method)
  • An employee or first-degree family member of an employee of the Sponsor or the Contract Research Organisation (CRO).
  • Unable to swallow tablets
  • Participants who have poor venous access or cannot tolerate venepuncture, IV cannula insertion or who have a fear of needles or blood
  • Any participant for whom the Investigator believes, for any reason, inclusion would not be an acceptable risk.
  • Consumption of grapefruit, grapefruit juice, or Seville oranges for 72 hours before the first dose of IP administration on Day 1.
  • Any clinically significant illness in the 30 days prior to Study Day 1.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment34 participants
  • Timeline
    Start: 2024-10-09
    End: 2025-12-31
  • Compounds
    KetamineKetamine
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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