A Phase 1, Single Centre, Randomised, Double... — Clinical Trial Details

Participants

Ages

18 – 60

Sexes

Male & Female

BMI

18 - 32

Psychosis History

Inclusion Criteria

To be eligible for this study, participants must meet all of the following inclusion criteria:
1. Healthy male or female volunteers aged between 18 to 60 years (inclusive) at the time of informed consent.
2. Capable of understanding the purposes and risks of the study and able to provide written informed consent before any study-specific screening procedures are performed.
3. Willing and able to adhere to all protocol requirements, including willingness to comply with scheduled visits.
4. Body weight = 50 kg, and a body mass index (BMI; Quetelet index) in the range 18.0 to 32.0, inclusive.
5. Subject is free from clinically significant (in the opinion of the Investigator) illness or disease as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
6. Adequate venous access in both arms for collection of a number of blood samples.
7. Negative urine drug/alcohol breath testing at Screening and prior to randomisation. Note: Screening urine drug test/alcohol breath testing may be repeated once if deemed appropriate by the Investigator.
8. Must have a negative COVID-19 PCR test on Day -1
9. If a subject is undergoing vaccination against Covid 19 virus, must wait 14 days after vaccination before first dose of investigational drug.
10. Female participants must meet 1 of the following criteria:
a) Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (i.e., no menses for at least 12 months). Postmenopausal status is to be confirmed by testing follicle-stimulating hormone [FSH] levels or local practice.
b) Of childbearing potential and agrees to take effective contraceptive measures throughout the study period (i.e., highly effective birth control method such as hormonal contraception or intrauterine device [IUD], or abstinence, when in line with preferred or usual lifestyle), from study entry (i.e., Screening) until at least 3 months after the last dose of study drug. Contraception requirements do not apply for participants in an exclusively same-sex relationship.
c) Of childbearing potential and in an exclusive relationship with a partner who has had a bilateral vasectomy at least 6 months prior to study entry.
11. Male participant: has undergone bilateral vasectomy (at least 6 months prior to study entry) and has documented evidence of azoospermia at least 90 days post procedure. or agrees to use effective contraceptive effective contraceptive measures (i.e. condoms for all types of sexual intercourse; plus use of a highly effective birth control method by their female partner, if they are of childbearing potential [see Inclusion Criteria 10]; or abstinence, when in line with preferred or usual lifestyle) and not donate sperm throughout the study period from study entry (i.e., Screening) until at least 3 months after the last dose of study drug.

Exclusion Criteria

A participant who meets any of the following exclusion criteria must be excluded from the study:
1. History of severe allergic or anaphylactic reactions, known intolerance, allergy or hypersensitivity reactions to Ketamine.
2. History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
3. Mean baseline blood pressure above 130/80 mm Hg.
4. History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure. A history of childhood febrile seizures is allowed.
5. Presence of current psychiatric condition or psychiatric condition requiring pharmacological management within the last 6 months.
6. Positive results of a screen for PTSD through a validated PTSD rating scale questionnaire
7. A calculated creatinine clearance of < 85 mL/minute at Screening or pre randomisation according to the equation using Cockcroft and Gault.
8. Liver function tests showing values for ALT or AST > 1.5 times ULN at Screening.
9. Evidence or history of clinically significant (in the opinion of the Investigator) other cardiovascular, pulmonary, neurologic or renal disorders or hepatic, gastrointestinal, oral (difficulty swallowing / taking oral medication), haematological, endocrine, or psychiatric impairment/disorders.
10. Have undergone surgery requiring or have received (for any reason) anaesthetic within 30 days of Day 1, or planned surgery during the study.
11. Use of CNS depressants including opioids, sedative, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquilisers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 30 days of Day 1. Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritonavir) within 30 days of Day 1. Thirty-day washout from these medications is required.
12. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 1 month or 5 half-lives of the specific drug/biologic (whichever is longer) prior to dosing.
13. Donation or loss of more than 500 mL of blood within 30 days of Day 1 and/or plans to donate blood during the study.
14. Use of any prescription medication within 14 days of Day 1 and for duration of study, unless approved by both the Investigator and the Medical Monitor (in writing). If necessary, paracetamol (acetaminophen) or ondansetron (or other 5-HT3 receptor antagonist) may be administered with the approval of the Investigator.

Company

Product

Legal

A Phase 1, Single Centre, Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

NeuroDirect Ketamine

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details