Comparative bioavailability assessment between R107 tablet and 60 mg ketamine IV solution administered orally in healthy male and female participants under fasting conditions.

Phase 1

Withdrawn

• Conditions: Depression; Anxiety; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12618001133224
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-10
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics (as summarised by Cmax and AUC). All plasma samples will be assayed for ketamine and norketamine using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.[Sampling immediately prior to dosing and at 30 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 32 and 48 hours post dosing.]

Secondary Outcome Measures

Name	Time	Method
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[Sampling immediately prior to dosing and at 30 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 32 and 48 hours post dosing.]