A Phase 1, Open-label, Single Cohort Study to... — Clinical Trial Details | Blossom
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A Phase 1, Open-label, Single Cohort Study to Evaluate the Safety and Pharmacokinetics (PK) of a Single Intravenous (IV) Infusion of TRP-8803 [Psilocin Besylate formulation] in Healthy Adult Participants
This open-label Phase I trial (n=4) evaluated the safety and efficacy of the intervention for binge eating disorder.
Orally administered psilocybin has shown promise as an effective treatment for a range of mental health disorders. Psilocybin is a prodrug that is rapidly converted in the body to its active form, psilocin. As such, the therapeutic effects observed in psilocybin studies are attributable to psilocin. TRP-8803 is a novel, intravenously administered formulation of synthesised psilocin. Previous studies conducted by the study Sponsor demonstrated that a hydrochloride (HCl) formulation of TRP-8803 was safe and well tolerated in healthy adult humans, with an acceptable pharmacokinetic profile. However, a new besylate formulation has been developed to enhance physicochemical stability and reduce hygroscopicity. These properties will support more reliable manufacturing, storage, and intravenous administration, without altering the identity of the primary psychoactive compound or safety profile of TRP-8803. This Phase 1 study will evaluate the safety and pharmacokinetics of TRP-8803 [Psilocin Besylate] in healthy adult participants to inform its further clinical development.
Study Arms & Interventions
Experimental Arm
experimental
Participants
Inclusion Criteria
Voluntary consent to participate in the study (including follow-up visits) and to undergo the procedures described.
Ability to take medication intravenously (i.e., has adequate venous access for IV administration) and be willing to adhere to the study regimen.
Locations
Unknown facility — Australia
Medically stable in the judgement of the Medical Officer and Lead Psychiatrist, as determined by screening medical, physical examination, ECG, and routine laboratory tests including blood and urinalysis.
Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consumes on a usual morning, before arriving at the research unit on the mornings of drug session day. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on a session day.
Agree to follow the directions of the Medical Officer regarding the consumption of non-prescription and prescription medications and supplements:
Agree that for 7 days before the psilocin administration day, including the morning of the dose, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the Medical Officer. Exceptions will include acetaminophen, non-steroidal anti-inflammatory drugs, common doses of vitamins and minerals, and contraceptives.
Agree that for 14 days before the study intervention administration session, participants must refrain from taking any prescription medication (except for hormonal contraceptives or hormone replacement therapy) except when approved by the Medical Officer. No pro re nata (PRN) medications are allowed on the morning of study intervention administration.
Agree that a support person will assist them personally with transport after each dosing session.
If required, successful withdraw of nominated medications prior to baseline.
Able to provide the contact detail of a medically qualified doctor or medical practice that they are a patient of and give consent for them to be contacted by a trial staff member.
Non- or ex-smokers and not use other nicotine-containing products from 90 days prior to Stage 1 Screening until participant study termination.
Weight between 50kg and 120 kg, inclusive; and body mass index (BMI) between 20 and 30 inclusive.
Has had no psychedelic drug use in the 3 months prior to psilocin administration visit and agrees to refrain from psychedelic drug use other than study drug during the course of the study by self-report. Psychedelic drugs include but are not limited to psilocybin, LSD, methylenedioxymethamphetamine (MDMA), and ayahuasca. If another suspected psychedelic agent is used, Sponsor must be contacted for approval.
Women of childbearing potential (WOCBP) in sexual relationships with men must use 2 acceptable methods of contraception from 30 days prior to study screening until 30 days after completing the dose of study intervention. Ova donation is not permitted for 30 days after completing the dose of study intervention.
Men must agree to avoid impregnation of women and sperm donation during and for 90 days after completing the dose of study intervention through use of an acceptable method of contraception.
NOTE: acceptable methods of contraception include, but are not limited to, intrauterine device; injected/implanted/intravaginal/transdermal hormonal method; oral hormones plus a barrier contraception; abstinence; vasectomized sole partner; or double barrier contraception (eg, barrier method). The 2 methods of contraception cannot both be hormonal.
Exclusion Criteria
Meets DSM-5 criteria for any psychiatric conditions (including personality disorders), ongoing experience or history of trauma, or other personal or situational factors (e.g., lacking social support, lacking a stable living situation, domestic violence, high autistic trait) judged by the investigating team as part of the eligibility review process to be incompatible with establishment of rapport or the safe exposure to treatment.
Recent (within 5 years) history of major depressive disorder, obsessive-compulsive disorder, generalized anxiety disorder, panic disorder, anorexia nervosa or bulimia nervosa, overeating disorder, posttraumatic stress disorder, or substance use disorder.
At the time of screening, experiencing mild levels of depression or greater.
Participant has a recent history of suicide attempt (defined as an active, interrupted, or aborted attempt with the past 5 years) or reports suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the C-SSRS performed at the Screening Visit
History of psychosis: past or present diagnosis DSM-5 of bipolar disorder, schizophrenia, or schizoaffective disorder.
Family history of psychosis: past or present DSM-5 diagnosis of bipolar disorder in first-degree relative, or schizophrenia, or schizoaffective disorder in first or second-degree relative.
Participant has a history of alcohol abuse disorder within 1 year prior to screening or regular abuse of alcohol (AUDIT > 8 at screening).
Meets DSM-5 criteria for substance use disorder (other than alcohol) within the past 12 months or regular abuse of substances (DAST-10 > 3 at screening).
Currently taking (or where applicable, testing positive on urine drug test), drugs of abuse such as amphetamines, buprenorphine, benzodiazepines, cocaine, methamphetamines, MDMA/Ecstasy, morphine, methadone, oxycodone, marijuana, ethyl glucuronide, fentanyl, tramadol, and synthetic cannabinoids (K2).
Prior adverse effects from psilocybin or other psychedelics (such as severe headache and/or severe hypertension requiring treatment) based on self-report.
History of HPPD.
Serious medical condition that, in the judgment of the medical officer and/or lead psychiatrist, will interfere with the ability so safety participate in the treatment e.g., Cardiovascular, Metabolic, Neurological, Respiratory, Oncological, haematological disorder, epilepsy or seizures.
Currently under treatment for epilepsy.
Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication). This could include patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 450 ms for men and above 470 ms for women), PR >220 msec, or QRS >120 msec
Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome
Serious abnormal haematology or electrolyte, renal or liver test result (indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 2 or total bilirubin greater than or equal to 1.5 x upper limit of normal (ULN), which remains above these limits if provided by their GP or assessed during the screening phase, unless there is specific medical clearance.
Insulin-dependent diabetes; if taking oral hypoglycaemic agents only excluded if they also have a history of hypoglycaemia.
Currently taking (within 5 half-lives dosing days) prohibited medications, including antihypertensive medications, UDP Glucuronosyltransferase Family 1 Member A9 (UGT1A9) or intestinal UDP-glucuronosyltransferases 1A10 inhibitors (eg, regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (eg, disulfiram).
Currently (for at least 2 weeks; or at least 4 weeks for fluoxetine) taking an antidepressant.
Serious infection requiring hospitalisation within the last 28 days.
Women of childbearing potential who are pregnant, nursing, or trying to become pregnant.
Participation in another clinical study involving investigational study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.
Any laboratory test results deemed clinically significant by the medical officer or lead psychiatrist or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
Not suitable for study participation due to other reasons at the discretion of the study investigators
Return a positive saliva drug test on the day of dosing, prior to session commencement.
Blood alcohol reading above zero on the day of dosing, prior to session commencement.
Donation of blood or blood product(s) >500mL within 30 days before screening.