CID-201-001: A Double-Blind, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Lucid-201 in Healthy Male and Female Volunteers and Patients with Depressive Symptoms on a selective-serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI)
- Conditions
- Mental HealthMental Health - Depression
- Registration Number
- ACTRN12623000423617
- Lead Sponsor
- FSD Pharma Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria (cohorts 1 – 4):
1.Healthy male and female volunteers, 18 – 60 years of age, inclusive at the time of informed consent.
2.Body mass index (BMI) that is within 18.0 – 32.0 kg/m2, inclusive, and minimum weight of 50 kg.
3.Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
4.QTcF interval less than or equal to 450 msec for males and less than or equal to 470 msec for females, unless deemed otherwise by the PI/Sub-Investigator.
5.Systolic blood pressure between 90 – 140 mmHg, inclusive, and diastolic blood pressure between 40 – 90 mmHg, inclusive, and heart rate between 40 – 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
6.Clinical laboratory values within the most recent acceptable laboratory test ranges and/or values are deemed by the PI/Sub-Investigator as Not Clinically Significant.”
7.Non-smoker, for at least 30 days prior to trial drug administration.
8.Ability to comprehend and be informed of the nature of the trial, as assessed by PI. Capable of giving written informed consent prior to any trial related procedure. Must be able to communicate effectively with clinic staff.
9.Ability to speak, read, and understand English sufficiently to allow completion of all trial assessments.
10.Ability to fast for at least 13 hours and the ability to consume standard meals.
11.Availability to volunteer for the entire trial duration and willing to adhere to all protocol requirements.
12.Agree not to have a tattoo or body piercing until the end of the trial.
13.Agree not to receive the COVID-19 vaccination or any other vaccination from seven days prior to the trial drug dose until after the follow-up visit.
14.Agree not to drive or operate heavy machinery if feeling dizzy, drowsy, or otherwise mentally impaired following trial drug administration until full mental alertness is regained.
15.Female participants must be non-pregnant and non-lactating and fulfill at least one of the following:
a.Be surgically sterile for a minimum of six months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).
b.Post-menopausal for a minimum of one year (postmenopausal is defined as twelve consecutive months with no menses without an alternative medical cause). An FSH test will be performed to confirm post-menopausal status.
c.Agree to avoid pregnancy and use an acceptable effective method of contraception with male sexual partners from at least 30 days prior to the trial until at least 30 days after the follow-up visit.
d.Acceptable effective methods of contraception include using a male condom in combination with oral contraceptives, hormonal patch, implant or injection, hormonal or /non-hormonal intrauterine device; or a double-barrier method (e.g., male condom in addition to pill, implant, or IUD). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the trial participant. Female participants with a vasectomised male partner are required to adhere to the acceptable contraception methods.
16.Males who are able to father children must agree to use an acceptable effective method of contraception with female sexual partners of child-bearing potential and not donate sperm during the trial and for at least 30 days after the last
Exclusion Criteria (cohorts 1 – 4):
1.Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
2.Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within seven days prior to first trial drug administration, as determined by the PI/Sub-Investigator.
3.History of seizures, including once off for both the participant and their first-degree relatives with history of seizures, history of head trauma with the exception of fully resolved minor concussions (no hospitalization or loss of consciousness), history of neurosurgery, or first-degree relatives with idiopathic generalized epilepsy or other congenital epilepsies.
4.Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
5.Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
6.A positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C.
7.A positive test result for drugs with abuse potential (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol), alcohol (via breathalyzer test), and/or cotinine.
8.Positive pregnancy test for female participants.
9.Known history or presence of:
a.Hypersensitivity or idiosyncratic reaction to psilocybin, psilocin and/or related substances and/or excipients;
b.Clinically significant food allergies;
c.Presence of any dietary restrictions unless deemed by the PI/Sub-I as Not Clinically Significant;”
d.Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
10.Psychiatric exclusion criteria:
a.Current or past history of schizophrenia spectrum, psychotic disorder (unless due to a medical condition), or bipolar I or II disorder.
b.Current or past history within the last two years of alcohol or drug dependence (excluding caffeine and nicotine).
c.Current or past history within the last five years of major depressive disorder, obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa.
d.Have a first-degree relative with schizophrenia spectrum, psychotic disorder (unless substance-induced or due to a medical condition), or bipolar I or II disorder.
e.Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocin.
f.Suicidal ideation or active suicidality, based on C-SSRS results.
11.Intolerance to and/or difficulty with blood sampling through venipuncture.
12.Use of psychedelics (e.g., psilocybin or ‘magic mushrooms,’ LSD, mescaline, DMT, ayahuasca) in the past two years or more than five times in lifetime.
13.Individuals who have donated, in the days prior to first trial drug administration:
a.>400 mL of blood in the previous 30 days;
b.500 mL or more in the previous 56 days.
14.D
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method