depression Major depressive disorder
Conditions
Interventions
Part A: single dose of GM-1020 or placebo
Part B: 4 doses of GM-1020 or placebo (every other day in a timespan of 1 week)
Part C: single dose of GM-1020, 2 times
Sponsors
Gilgamesh Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female or male subjects, 18 to 55 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical, surgical a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. 2. Subject has a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive (BMI=weight/height2) at screening. 3. Subjects must be willing to adhere to the prohibitions and restrictions specified in the protocol, including attending all study visits and completing all study evaluations. 4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the study and are willing to participate in the study. Agree to refrain from using any psychoactive drugs from 30 days before first dosing and until the last follow up visit and to refrain from using alcoholic beverages within 48 hours prior to admission of each treatment period.
Exclusion criteria
Exclusion criteria: 1. Clinically significant current or previous liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, metabolic or inflammatory illness, or any other illness that would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements according to the investigator. 3.Subject has a history of or current hypertension (resting systolic blood pressure > 130 mmHg or diastolic blood pressure >90 mmHg) at screening. 5. Resting heart rate (HR) greater than 100 or less than 45 beats per minute (bpm) at screening. 7. Clinically significant current or previous psychiatric disorder according to DSM 5. 8. Family history of a psychotic disorder in first-degree and second-degree relatives. 9. Clinically significant current or previous suicidality based on the C-SSRS and psychiatric history indicating current suicidal ideation or a history of active suicidal ideation or suicide attempts 10. Subject has a current or history of drug or alcohol use disorder according to DSM 5 within the past 12 months. 11. Structural use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, or psychedelics) during the 6 weeks prior to screening. Ingestion of psilocybin, DMT, LSD, MDMA, or another serotonergic psychedelic within the last 4 weeks. 12. Persistent psychological effects following the previous use of psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or ketamine. Such effects might include but are not limited to anxiety, depressed mood, paranoid ideation and/or hallucinations (including hallucinogen persisting perception disorder - HPPD) or recurrent flashbacks related to use. 13. Subject has a positive test result(s) for alcohol and/or drugs of abuse (including opiates, cocaine, amphetamines, methamphetamines, cannabinoids, ketamine and benzodiazepines) at screening or admission to the clinical unit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, Part B Safety and tolerability endpoints: AE*s, vital signs, 12-lead ECG, , laboratory safety tests (routine haematology, biochemistry and urinalysis), occurrence of psychotic symptoms (BPRS),emergence of suicidal thoughts and ideations (CSSRS) modified observer*s assessment of alertness and sedation scale (MOAA/S), and concomitant medications. Part C Plasma and urine PK endpoints GM-1020 and metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A Plasma and urine PK endpoints GM-1020 and metabolites. PD endpoints: Neurophysiological/neuropsychological test battery (Neurocart); Rating scales; and behavioral assessments Part B Plasma and urine PK endpoints GM-1020 and metabolites. PD endpoints: o Visual Analogue Scales Bond and Lader (VAS B&L) o VAS Bowdle (VAS Bowdle) and VAS Drug rating (subjective drug effects) and Drug Effects Questionnaire (DEQ) o Pharmaco-EEG (pEEG) Rating scales: o Clinician-Administered Dissociative Symptoms Scale (CADSS) o 5-Dimension Altered States of Consciousness Rating Scale (5D-ASC) o Mystical Experiences Questionnaire (MEQ30) o Real-time intensity scale behavioral assessments Part C Safety and tolerability endpoints AE*s, vital signs, 12-lead ECG, , laboratory safety tests (routine haematology, biochemistry and urinalysis), occurrence of psychotic symptoms (BPRS),emergence of suicidal thoughts and ideations (CSSRS) modified observer*s assessment of alertness and sedation scale (MOAA/S), and concomitant medications PD endpoints: o Visual Analogue Scales Bond and Lader (VAS B&L) o VAS Bowdle (VAS Bowdle) en Drug Effects Questionnaire (DEQ) Rating scales: o Clinician-Administered Dissociative Symptoms Scale (CADSS) o 5-Dimension Altered States of Consciousness Rating Scale (5D-ASC) | — |
Countries
Netherlands
Outcome results
None listed