None listed
Conditions
Brief summary
The primary objective of this study is to evaluate the comparative bioavailability of the test formulation relative to that of a reference formulation, following oral administration of a single dose of 3 x 60 mg R-107-H extended release tablets and 3 x 60 mg R-107-P extended release tablets in healthy participants under fasting conditions. In lay terms this means we are comparing one R-107 formulation (R-107-H) to another R-107 formulation (R-107-P) that both contain the same amount of active ingredient but some of the other ingredients differ between the two making them different formulations of the R-107 extended-release tablet.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of 3 x 60 mg R-107-H extended release (ER) tablets on one occasion.
The intervention for this trial is the test R-107-H formulation. The active ingredient in R-107-H is ketamine.
The duration of the study is approximately 6 weeks;
- Up to 3 weeks for screening;
- Two study periods each occurring over 3 days with dose administration on day 1 and clinical procedures and PK sample collection during each 3
Single dose, crossover study design whereby each participant receives the test formulation of 3 x 60 mg R-107-H extended release (ER) tablets on one occasion. The intervention for this trial is the test R-107-H formulation. The active ingredient in R-107-H is ketamine. The duration of the study is approximately 6 weeks; - Up to 3 weeks for screening; - Two study periods each occurring over 3 days with dose administration on day 1 and clinical procedures and PK sample collection during each 3 day study period; - Minimum of 1-week washout period between each dose administration period and 1 day for study exit procedures. The intervention formulation will be administered as a single dose on one occasion only i.e. 3 x 60 mg R-107-H tablets taken on Study Day 1, and will be taken orally with 240 ml of water at ambient temperature. The tablets will be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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: o As assessed by C-SSRS, or o 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.
Outcome results
None listed