Clinical TrialDepressive DisordersKetamineWithdrawn

A single dose, randomised, 2-period, 2-sequence, crossover, comparative bioavailability study between R107 tablet and 60 mg ketamine IV solution administered orally in healthy male and female participants under fasting conditions.

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

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

The objective of this study is to evaluate the comparative bioavailability of the test formulation relative to the that of a reference formulation, following oral administration of a single dose of R107 tablet or ketamine IV solution to healthy male and female subjects under fasting conditions.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • Healthy males and non-pregnant female volunteers.
  • Aged between 18 and 55
  • Non-smoker
  • BMI between 18.5 and 30
  • Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
  • The absence of mental illness requiring medication or treatment by a physician.
  • Able to provide written informed consent

Exclusion Criteria

  • Concomitant drug therapy of any kind
  • Any history of mental illness requiring medication or treatment by a physician.
  • Receiving treatment with monoamine oxidase inhibitors, vasoconstriction agents, thyroxine or benzodiazepines.
  • m) History of significant drug abuse or dependency including ketamine or its excipients within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
  • Sensitive to the study drug
  • History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
  • Females who are pregnant and/or breastfeeding
  • Smoker (anyone who has smoked in the last 6 months)
  • History of alcohol or drug abuse or dependency
  • Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
  • Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk

Study Details

  • Status
    Withdrawn
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2018-07-13
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Unknown facility — Australia

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