Safety, PK and PD of oral ketamine capsules
Research type
Research Study
Full title
A first-in-human, randomised, double blind, placebo controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ketamine in healthy volunteers.
IRAS ID
1004055
Contact name
Carmel Reilly
Contact email
Sponsor organisation
Neurocentrx Pharma Limited
Eudract number
2019-001019-22
Research summary
Ketamine is a synthetic drug created in the 1960’s. It is on the “essential medicine” list of the World Health Organisation (WHO), approved and licensed by health regulators worldwide as an injectable anaesthetic. More recently, and at sub-anaesthetic doses, clinical trials
have shown that some patients with depression have a rapid response to ketamine (hours or days).
Most anti-depressant medicines take many weeks to work. Some patients have “treatment resistant depression” (TRD) meaning that these standard medications do not seem to work. A nasal Ketamine spray has recently been approved for TRD. However nasal sprays have problems: coordination issues, a hit-like effect, inconsistency of delivery, nausea and vomiting, high pricing, lack of convenience and supervision requirements. Spray containers are also more costly and less environmentally friendly. Oral delivery could solve some of these issues and reduce others.
Neurocentrx has developed oral capsule formulations of Ketamine hydrochloride (called "KET-IR"). No oral ketamine products are currently available as a licensed medicine worldwide. The trial will assess oral capsules of ketamine in healthy people in a clinical trial. We will assess absorption and excretion with increasing doses of product and measure any side-effects. These data will be essential to accurately plan future trials in patients with mood disorders where we will look for benefits to depression episodes.
This new formulation will be tested during this trial in 18 healthy people where the absorption rates will be measured, along with the dosing and any side-effects being monitored. The purpose of this research is to investigate how the body may react to the drug KET-IR, as well as how the drug KET-IR affects the body. It will be at a single-site in London, the Wellcome/NIHR Clinical Research Facility at the Maudsley Hospital, London, and is expected to last 6 months.REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0711
Date of REC Opinion
22 Nov 2021
REC opinion
Further Information Favourable Opinion