A study comparing two formulations of R-107 under... — Clinical Trial Details

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

18.5 - 33

Psychosis History

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

R-107-H (test)

Interventions

R-107-P (reference)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details