A Three-Part, Adaptive, Randomized, Double blind, Placebo Controlled First in Human Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of GM-1020 and the Effect of Food on Single Dose GM-1020 in Healthy Volunteers.

Completed

• Conditions: depression; Major depressive disorder; 10027946

• Registration Number: NL-OMON53597
• Lead Sponsor: Gilgamesh Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 116

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A, Part B<br /><br><br /><br>Safety and tolerability endpoints:<br /><br>AE*s, vital signs, 12-lead ECG, , laboratory safety tests (routine<br /><br>haematology, biochemistry and urinalysis), occurrence of psychotic symptoms<br /><br>(BPRS),emergence of suicidal thoughts and ideations (CSSRS) modified observer*s<br /><br>assessment of alertness and sedation scale (MOAA/S), and concomitant<br /><br>medications.<br /><br><br /><br>Part C<br /><br>Plasma and urine PK endpoints GM-1020 and metabolites</p><br>