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Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05821387
Recruitment Status : Completed
First Posted : April 20, 2023
Last Update Posted : August 29, 2023
Sponsor:
Collaborator:
Lucid Psycheceuticals Inc. (sub of FSD Pharma, Inc.)
Information provided by (Responsible Party):
FSD Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE March 21, 2023
First Posted Date  ICMJE April 20, 2023
Last Update Posted Date August 29, 2023
Actual Study Start Date  ICMJE March 22, 2023
Actual Primary Completion Date July 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2023)
  • Single Dose Safety Outcome Measures [ Time Frame: Up to 12 days ]
    Incidence and severity of adverse events (AEs), laboratory, ECG, physical exam, neurological exam and vital sign changes
  • AUC from time zero to the last non-zero concentration after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Cmax after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Tmax after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • AUC0-inf after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • t1/2 after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Kel after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • CL/F after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Vd/F after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Effect of Food on the single dose AUC from time zero to the last non-zero concentration [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Cmax [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Tmax [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose AUC0-inf [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose t1/2 [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Kel [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose CL/F [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Vd/F [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2023)
  • Single Dose Safety Outcome Measures [ Time Frame: Up to 12 days ]
    Incidence and severity of adverse events (AEs), laboratory, ECG, physical exam, neurological exam and vital sign changes
  • Multiple Dose Safety Outcome Measures [ Time Frame: Up to 18 days ]
    Incidence and severity of adverse events (AEs), laboratory, ECG, physical exam, neurological exam and vital sign changes
  • AUC from time zero to the last non-zero concentration after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Cmax after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Tmax after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • AUC0-inf after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • t1/2 after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Kel after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • CL/F after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Vd/F after single dose [ Time Frame: Pre-dose to 48 hours post-dose ]
    PK characteristics after single dose
  • Effect of Food on the single dose AUC from time zero to the last non-zero concentration [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Cmax [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Tmax [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose AUC0-inf [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose t1/2 [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Kel [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose CL/F [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • Effect of Food on the single dose Vd/F [ Time Frame: Pre-dose to 48 hours post-dose ]
    Effect of food on the single dose PK
  • AUC0-24h after multiple doses [ Time Frame: Pre-dose to 24 hours post dose on Day 1; pre-dose to 24 hours post-dose on Day 4; pre-dose to 24 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Cmax after multiple doses [ Time Frame: Pre-dose to 24 hours post dose on Day 1; pre-dose to 24 hours post-dose on Day 4; pre-dose to 24 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Tmax after multiple doses [ Time Frame: Pre-dose to 24 hours post dose on Day 1; pre-dose to 24 hours post-dose on Day 4; pre-dose to 24 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • AUC0-tau after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Cmax at steady-state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Tmax at steady-state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Cmin at steady-state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Cav at steady-state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Observed concentration at the end of the dosing interval at steady state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • RAC(AUC) after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • RAC(Cmax) after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • AUC from time zero to the last non-zero concentration after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • AUC0-inf after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • t1/2 after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Kel after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • CL/F at steady state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
  • Vd/F at steady state after multiple doses [ Time Frame: Pre-dose to 48 hours post-dose on Day 7 ]
    PK characteristics after multiple doses
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Lucid-21-302 in Healthy Volunteers Under Fed and Fasted Conditions
Brief Summary This study aims to determine the safety, tolerability, and pharmacokinetics of single doses of Lucid-21-302 in healthy adult volunteers. This study will also investigate the effects of food in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
5 SAD Cohorts. Each SAD cohort will enroll 8 participants randomized 6 active:2 placebo to receive single doses of Lucid-21-302. For SAD cohort with food effect, all 8 participants will receive Lucid-21-302.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Lucid-21-302
    A small molecule inhibitor of hypercitrullination
  • Drug: Placebo
    Product containing excipients with no active ingredients
Study Arms  ICMJE
  • Experimental: Lucid-21-302
    Single-ascending dose cohorts
    Intervention: Drug: Lucid-21-302
  • Placebo Comparator: Placebo
    Single-ascending dose cohorts
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2023)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2023)
56
Actual Study Completion Date  ICMJE July 29, 2023
Actual Primary Completion Date July 29, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 18.5 - 30.0 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 ≤ 440 msec for males and ≤ 460 msec for females, unless deemed otherwise by the PI/Sub-Investigator.
  5. Systolic blood pressure between 95 - 140 mmHg, inclusive, and diastolic blood pressure between 55 - 90 mmHg, inclusive, and heart rate between 50 - 100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
  6. Clinical laboratory values within the laboratory test ranges and/or values in the clinical site's SOPs that are classified as "Not Clinically Significant."
  7. Non-smoker and non-nicotine user, for at least six months prior to study drug administration.
  8. Ability to comprehend and be informed of the nature of the study, as assessed by PI. Capable of giving written informed consent prior to any study 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 study assessments.
  10. Ability to consume standard meals and the ability to fast for at least 14 hours for the SAD study and at least ten hours for the MAD study.
  11. Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
  12. Agree not to have a tattoo or body piercing until the end of the study.
  13. Agree not to receive the COVID-19 vaccination or other vaccination from seven days prior to the study drug dose until seven days after study drug administration in the study.
  14. Agree not to drive or operate heavy machinery if feeling dizzy, drowsy, or otherwise mentally impaired following study 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:

    • 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).
    • Post-menopausal for a minimum of one year (postmenopausal is confirmed by serum FSH values collected at screening).
    • Agree to avoid pregnancy and use an acceptable effective method of contraception with male sexual partners from at least 30 days prior to the study until at least 30 days after the study has ended (last study procedure).
    • Acceptable effective methods of contraception include using a male condom in conjunction with non-hormonal contraceptives, such as a non-hormonal intrauterine device; or a double-barrier method (e.g., male condom with diaphragm and spermicide used simultaneously, male condom with cervical cap and spermicide used simultaneously). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
  16. Males who are able to father children must agree to use an acceptable effective method of contraception with female sexual partners of childbearing potential and not donate sperm during the study and for at least 90 days after the last dose of the study drug (Lucid-21-302 or placebo).

    • Acceptable effective methods of contraception include using a male condom with a female sexual partner of childbearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device or system; or a double-barrier method (e.g., male condom with diaphragm and spermicide used simultaneously, male condom with cervical cap and spermicide used simultaneously). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
    • If a participant's partner becomes pregnant during his participation in the study and for 90 days after he has completed his last study drug administration, he must inform site staff immediately.
  17. Deemed suitable for the study by the PI/Sub-Investigator and/or clinical staff.

Exclusion Criteria:

  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.

    o AST, ALP, ALT, bilirubin, and/or GGT levels that are outside of normal laboratory ranges

  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 study drug administration, as determined by the PI/Sub-Investigator.
  3. History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or first-degree relative 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 (cannabis, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), breath alcohol test or urine cotinine test.
  8. Positive pregnancy test for female participants.
  9. Known history or presence of:

    • Food allergies;
    • Presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant;"
    • Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
  10. Intolerance to and/or difficulty with blood sampling through venipuncture.
  11. Individuals who have donated, in the days prior to first study drug administration:

    • 50-499 mL of blood in the previous 30 days;
    • 500 mL or more in the previous 56 days.
  12. Donation of plasma by plasmapheresis within 7 days prior to study drug administration.
  13. Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to study drug administration.
  14. Use of any enzyme-modifying drugs and/or other products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days before study drug administration.
  15. Use of any prescription medication within 14 days prior to study drug administration.
  16. Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 14 days prior to study drug administration.
  17. Consumption of food or beverages containing grapefruit and/or pomelo within 10 days prior to study drug administration.
  18. Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hr before dosing (includes coffee and tea).
  19. Individuals having undergone any major surgery within six months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
  20. Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
  21. Difficulty with swallowing tablets or capsules.
  22. Have had a tattoo or body piercing within 30 days prior to study drug administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05821387
Other Study ID Numbers  ICMJE Lucid-21-302-001
2786 ( Other Identifier: Biopharma Services Incorporated )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party FSD Pharma, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE FSD Pharma, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Lucid Psycheceuticals Inc. (sub of FSD Pharma, Inc.)
Investigators  ICMJE
Principal Investigator: Isabella Szeto, MD Biopharma Services Incorporated
PRS Account FSD Pharma, Inc.
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP