BridgeMD
A randomized, double-blind, single-center, 2-period cross-over Phase I study to assess the tolerability, safety and pharmacokinetics of antidepressant doses of oral ketamine hydrochloride prolonged release tablets (KET01) compared to intranasal esketamine in healthy male subjects
EU CTIS ID: 2023-503971-45-00
What this study is testing
To investigate the tolerability of a single dose of KET01 (240 mg) compared to intranasal esketamine (84 mg; active comparator) with respect to dissociative symptoms assessed by change in Clinician-Administered Dissociative States Scale (CADSS) total score in healthy male subjects.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be between ≥ 18 and ≤ 45 years of age at the time of signing the informed consent.
- Certified as healthy by a comprehensive clinical assessment (including detailed medical history)
- BMI between 18.5 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg.
- Male
You likely can't join if
- Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway (e.g. nasal piercing); obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis on days of IMP administration) or surgery in medical history which may have an impact on absorption as assessed by the investigator.
- Any previous administration or use of ketamine and esketamine (including known or suspected es-/ketamine-anesthesia), or other ketamine-related and/or dissociative drugs (e.g. phencyclidine [PCP]), Nitrous Oxide or dextromethorphan [at doses higher than the recommended therapeutic dose for cough suppression])
- History or presence of any clinically significant disease or disorder including (but not limited to) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, respiratory/pulmonary, gastrointestinal, psychiatric, neurological, musculoskeletal, endocrine , metabolic, malignant or major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study.
- Subjects with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders.
- Family history of sudden cardiac death in first-degree relatives.
- History of alcohol use disorder or substance use disorder, including e.g. benzodiazepines, opiates, hallucinogens and related drugs, stimulants (e.g. 3,4-methylenedioxymethamphetamine [MDMA], amphetamines, cocaine) or cannabis, except nicotine and caffeine, or a positive drug abuse test.
See the full eligibility criteria
Who can join
- Participant must be between ≥ 18 and ≤ 45 years of age at the time of signing the informed consent.
- Certified as healthy by a comprehensive clinical assessment (including detailed medical history)
- BMI between 18.5 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg.
- Male
What rules you out
- Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway (e.g. nasal piercing); obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis on days of IMP administration) or surgery in medical history which may have an impact on absorption as assessed by the investigator.
- Any previous administration or use of ketamine and esketamine (including known or suspected es-/ketamine-anesthesia), or other ketamine-related and/or dissociative drugs (e.g. phencyclidine [PCP]), Nitrous Oxide or dextromethorphan [at doses higher than the recommended therapeutic dose for cough suppression])
- History or presence of any clinically significant disease or disorder including (but not limited to) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, respiratory/pulmonary, gastrointestinal, psychiatric, neurological, musculoskeletal, endocrine , metabolic, malignant or major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study.
- Subjects with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders.
- Family history of sudden cardiac death in first-degree relatives.
- History of alcohol use disorder or substance use disorder, including e.g. benzodiazepines, opiates, hallucinogens and related drugs, stimulants (e.g. 3,4-methylenedioxymethamphetamine [MDMA], amphetamines, cocaine) or cannabis, except nicotine and caffeine, or a positive drug abuse test.
- Hypertension (after 5 minutes of rest, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) at Visit 1.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.