An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics
NCT ID: NCT05478278
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2022-06-22
2023-08-09
Brief Summary
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Detailed Description
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Part two of this study will be an open-label, randomized, 2-period, 2-sequence crossover design in 24 healthy volunteers (adult male and/or female subjects). Each assigned treatment will be administered under fasting or fed conditions as a single dose on Day 1 of the respective study period.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Part 1: Treatment A (IP at Therapeutic Dose)
A single therapeutic dose of psilocybin.
Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Part 1: Treatment B (IP at Supratherapeutic Dose)
A single supratherapeutic dose of psilocybin.
Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Part 1: Treatment C (Placebo - Negative Control)
A single dose of placebo-to-match psilocybin MCC capsules.
Micro-Crystalline Cellulose
The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
Part 1: Treatment D (Placebo - Positive Control)
A single 400 mg dose of moxifloxacin.
Moxifloxacin
The positive comparator used in this study is a 400 mg moxifloxacin tablet.
Part 2: IP at Therapeutic Dose (Fasted Conditions)
A single therapeutic dose of psilocybin administered under fasted conditions.
Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Part 2: IP at Therapeutic Dose (Fed Conditions)
A single therapeutic dose of psilocybin under fed conditions.
Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Interventions
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Psilocybin
The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
Moxifloxacin
The positive comparator used in this study is a 400 mg moxifloxacin tablet.
Micro-Crystalline Cellulose
The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Healthy adult male or female
* Aged at least 18 years but not older than 65 years, inclusive
* Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 (for Part 1) or to 33.0 kg/m2 (for Part 2), inclusively
Exclusion Criteria
* Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
* History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
* Showing suicidal ideation or behavior as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening
* Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTcF \> 450 msec for males and \> 470 for females) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
* History of risk factors for Torsades de Pointes (TdP), including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesaemia
* Family history of long QT syndrome or Brugada syndrome
* Any clinically significant illness in the 28 days prior to the first study drug administration
* Intake of psilocybin or any other psychedelic (including 3,4-methylenedioxymethamphetamine \[MDMA\] and ketamine) in the 28 days prior to the first study drug administration
* Not suitable for participation in the study at the discretion of the Principal Investigator
18 Years
65 Years
ALL
Yes
Sponsors
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Usona Institute
OTHER
Responsible Party
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Locations
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Altasciences Clinical Kansas, Inc
Overland Park, Kansas, United States
Countries
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References
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Carhart-Harris RL, Leech R, Hellyer PJ, Shanahan M, Feilding A, Tagliazucchi E, Chialvo DR, Nutt D. The entropic brain: a theory of conscious states informed by neuroimaging research with psychedelic drugs. Front Hum Neurosci. 2014 Feb 3;8:20. doi: 10.3389/fnhum.2014.00020. eCollection 2014.
Nichols DE. Hallucinogens. Pharmacol Ther. 2004 Feb;101(2):131-81. doi: 10.1016/j.pharmthera.2003.11.002.
Passie T, Seifert J, Schneider U, Emrich HM. The pharmacology of psilocybin. Addict Biol. 2002 Oct;7(4):357-64. doi: 10.1080/1355621021000005937.
Carhart-Harris RL, Nutt DJ. Experienced drug users assess the relative harms and benefits of drugs: a web-based survey. J Psychoactive Drugs. 2013 Sep-Oct;45(4):322-8. doi: 10.1080/02791072.2013.825034.
Nutt DJ, King LA, Phillips LD; Independent Scientific Committee on Drugs. Drug harms in the UK: a multicriteria decision analysis. Lancet. 2010 Nov 6;376(9752):1558-65. doi: 10.1016/S0140-6736(10)61462-6. Epub 2010 Oct 29.
Hasler F, Bourquin D, Brenneisen R, Bar T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997 Jun;72(3):175-84. doi: 10.1016/s0031-6865(97)00014-9.
Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.
Madsen MK, Fisher PM, Burmester D, Dyssegaard A, Stenbaek DS, Kristiansen S, Johansen SS, Lehel S, Linnet K, Svarer C, Erritzoe D, Ozenne B, Knudsen GM. Psychedelic effects of psilocybin correlate with serotonin 2A receptor occupancy and plasma psilocin levels. Neuropsychopharmacology. 2019 Jun;44(7):1328-1334. doi: 10.1038/s41386-019-0324-9. Epub 2019 Jan 26.
Manevski N, Kurkela M, Hoglund C, Mauriala T, Court MH, Yli-Kauhaluoma J, Finel M. Glucuronidation of psilocin and 4-hydroxyindole by the human UDP-glucuronosyltransferases. Drug Metab Dispos. 2010 Mar;38(3):386-95. doi: 10.1124/dmd.109.031138. Epub 2009 Dec 10.
Hasler F, Bourquin D, Brenneisen R, Vollenweider FX. Renal excretion profiles of psilocin following oral administration of psilocybin: a controlled study in man. J Pharm Biomed Anal. 2002 Sep 5;30(2):331-9. doi: 10.1016/s0731-7085(02)00278-9.
Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N. Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60.
Ferber G, Zhou M, Darpo B. Detection of QTc effects in small studies--implications for replacing the thorough QT study. Ann Noninvasive Electrocardiol. 2015 Jul;20(4):368-77. doi: 10.1111/anec.12227. Epub 2014 Nov 4.
Huang DP, Chen J, Dang Q, Tsong Y. Assay sensitivity in "Hybrid thorough QT/QTc (TQT)" study. J Biopharm Stat. 2019;29(2):378-384. doi: 10.1080/10543406.2018.1535498. Epub 2018 Oct 22.
Dahmane E, Hutson PR, Gobburu JVS. Exposure-Response Analysis to Assess the Concentration-QTc Relationship of Psilocybin/Psilocin. Clin Pharmacol Drug Dev. 2021 Jan;10(1):78-85. doi: 10.1002/cpdd.796. Epub 2020 Apr 6.
Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y. Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):383-397. doi: 10.1007/s10928-017-9558-5. Epub 2017 Dec 5.
Sischka PE, Costa AP, Steffgen G, Schmidt AF. The WHO-5 well-being index - validation based on item response theory and the analysis of measurement invariance across 35 countries. Journal of Affective Disorders Reports. 2020;1(100020).
Related Links
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ICH Safety Guidelines
Other Identifiers
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PSIL102-TQT
Identifier Type: -
Identifier Source: org_study_id
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