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Trichomylin® Safety, Tolerability, and Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation (HOPE)

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ClinicalTrials.gov Identifier: NCT04867057
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : June 7, 2021
Sponsor:
Collaborators:
Novotech (Australia) Pty Limited
ZYUS Life Sciences Australia Pty Ltd
Information provided by (Responsible Party):
ZYUS Life Sciences Inc.

Brief Summary:
This is a first in human, randomized, double blind, SAD (with food effect) followed by a MAD study of Trichomylin® conducted in healthy adult participants.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Trichomylin for SAD Drug: Placebo for SAD Drug: Trichomylin for MAD Drug: Placebo for MAD Phase 1

Detailed Description:

The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of Trichomylin® in healthy adult participants.

Up to 56 participants will be enrolled into 1 of 4 SAD cohorts (8 per cohort) and 3 MAD cohorts (8 per cohort). Participants will undergo a Screening period between 21 days and 28 days prior to randomization/dose administration (for SAD and MAD respectively), admission to the clinical research unit (CRU), pre-dose assessment, post-dose assessment, and a final end of study (EOS)/follow-up or early termination (ET) visit (if applicable).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 First in Human, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, PK/PD and Food Effect of Trichomylin in Healthy Adult Participants and Preliminary Efficacy in Management of Chronic Osteoarthritis Pain
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : February 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Experimental: Trichomylin for SAD
6 out of 8 subjects will be randomized to receive Trichomylin in a single dose.
Drug: Trichomylin for SAD
Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.

Placebo Comparator: Placebo Comparator: Placebo for SAD
2 out of 8 subjects will be randomized to receive placebo in a single dose.
Drug: Placebo for SAD
Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.

Experimental: Experimental: Trichomylin for MAD
6 out of 8 subjects will be randomized to receive Trichomylin in multiple doses.
Drug: Trichomylin for MAD
Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally for total of 9 days of dosing.

Placebo Comparator: Placebo Comparator: Placebo for MAD
2 out of 8 subjects will be randomized to receive Placebo in multiple doses.
Drug: Placebo for MAD
Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally for total of 9 days of dosing.




Primary Outcome Measures :
  1. Percentage and severity of unexpected Serious Adverse Events (SAEs) [ Time Frame: Through study completion, an average of 1 year ]
    To investigate the safety and tolerability of Trichomylin by assessment of the percentage and severity of SAEs following administration of oral soft-gel capsules in Single Ascending Dose (SAD Cohort) and Multiple Ascending Doses (MAD Cohort)


Secondary Outcome Measures :
  1. Rate and extent of absorption of Trichomylin by assessment of the observed Maximum Plasma Concentration (Cmax) [ Time Frame: SAD cohort: Day 1 through Day 21; MAD cohort: Day 1 through 30 ]
    To assess the observed Maximum Plasma Concentration (Cmax) for SAD and MAD cohorts

  2. Rate and extent of absorption of Trichomylin by assessment of the observed Time to Maximum Plasma Concentration (Tmax) [ Time Frame: SAD cohort: Day 1 through Day 21; MAD cohort: Day 1 through 30 ]
    To assess the observed Time to Maximum Plasma Concentration (Tmax) for SAD and MAD cohorts

  3. Rate and extent of absorption of Trichomylin by assessment of the observed Apparent Terminal Elimination Rate Constant (Kel) [ Time Frame: SAD cohort: Day 1 through Day 21; MAD cohort: Day 1 through 30 ]
    To assess the observed Apparent Terminal Elimination Rate Constant (Kel) for SAD and MAD cohorts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female volunteers, aged 18 to 65 years (inclusive at the time of consent);
  2. Must have a Body Mass Index (BMI) ≥ 18 to ≤ 32 kg/m2 with weight ≥ 50 kg at Screening;
  3. Must have a negative urine drug screen at the Screening visit and the day before dosing (Day -1); one repeat urine drug may be conducted for a suspected false positive result;
  4. Must be willing to abstain from the use of cannabis and other cannabinoid compounds (other than the study drug) for the duration of the study (from the time of Screening until the EOS visit);
  5. Must be willing to abstain from smoking (including the use of tobacco or nicotine products and e-cigarettes) for the duration of the study (from the time of Screening until the EOS visit);
  6. Must not have any hepatic and/or renal impairment as judged by the PI;
  7. Must be willing and able to comply with all study procedures and be available for the duration of the study (from the time of Screening until the EOS visit);
  8. Must not be currently using anti-depressants (selective serotonin reuptake inhibitors [SSRIs], monoamine oxidase inhibitors [MOAIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], or tricyclic anti-depressants [TCAs]) for 14 days or 5 half-lives of the drug, whichever is longer, prior to IP administration, and for the duration of the study;
  9. Must not have any current or past allergic or adverse reaction or known sensitivity to olive oil, gelatin, glycerin and titanium dioxide, or to cannabinoid-like substances (including but not limited to Dronabinol/Marinol/Nabilone/marijuana/cannabis/tetrahydrocannabinol [THC], cannabinoid oil);
  10. Females must be non-pregnant and non-lactating, and must use acceptable, highly effective double barrier contraception from Screening until study completion, including the follow-up period. Double contraception is defined as a condom AND one other form of the following:

    1. Established hormonal contraception (i.e. approved oral contraceptive pills)
    2. Long-acting implantable hormones, injectable hormones;
    3. A vaginal ring or an intrauterine device ([IUD], with or without hormones);
    4. Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner).

    Women not of childbearing potential must be post-menopausal for ≥ 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/mL at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.

    Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.

    Female participants who are in same-sex relationships are not required to use contraception.

  11. Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD.

    Males who are abstinent from heterosexual intercourse will also be eligible and must agree to complete abstinence for the duration of the study and for 1 month after the last study treatment.

    Male participants with same-sex partners are eligible when this is their preferred and usual lifestyle.

  12. Women of childbearing potential must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests, as required, throughout the study, at the Investigator's discretion;
  13. Males must not donate sperm and females must not donate ova for at least 90 days after the last dose of study drug;
  14. Must agree to adhere to the current state and national advice regarding minimizing exposure to corona virus disease of 2019 (COVID-19) from the first Screening visit until the EOS visit;
  15. Must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
  16. Must be in good physical and mental health as determined by absence of any clinically significant (in the opinion of the Investigator) abnormalities based on medical history, physical examination, vital signs, electrocardiogram (ECG), clinical laboratory evaluations, at Screening and prior to administration of the initial dose of study drug;
  17. Must be able and willing to comply with all study requirements including:

    1. Confinement to the CRU prior to and during study drug administration and required follow-up periods for Part A SAD and Part B MAD
    2. Refraining from using the following:

    i. Any previous/current cannabis products within 2 months prior to Screening and throughout the duration of the study (from the time of Screening until the EOS visit); ii. Cannabis products (in the form of oil, vaporizer, or smoke) for the duration of the study; iii. Prescription medications 14 days prior to administration of the first dose of study drug; iv. Alcohol 48 hours prior to admission, and while confined to the CRU. In addition, participants must agree to refrain from regular use of alcohol (i.e. ˃ 10 units per week or ˃ 4 units on any given day for men and women [1 unit = 150mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) for the duration of the study; v. Recreational drugs for the duration of the study.

  18. For Part A SAD, participants must not have used cannabis or cannabinoid products within 2 months prior to Screening.

Exclusion Criteria:

  1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
  2. Has a past or present clinically significant condition, which would prevent or limit study assessments in accordance with the protocol, with particular reference to renal and/or hepatic impairment, OR it would be in the best interests of the participant to not participate;
  3. Has been diagnosed with the following within 10 years of Screening: psychosis (secondary to, for example, substance abuse, major depression, a mood disorder with postpartum onset, bipolar disorder, schizophrenia, or borderline personality disorder), somatoform disorder(s) or chronic fatigue syndrome;
  4. Has a current/active diagnosis of generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post- traumatic stress disorder, a simple phobia(s), anorexia nervosa or bulimia nervosa;
  5. Cognitive impairment and/or a psychiatric illness (e.g., dementia, Alzheimer's disease or psychosis), which in the opinion of the Investigator will prevent participants from reliably providing primary outcome data;
  6. Has significant suicidal ideation as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9);
  7. History of abuse of substances such as opiates, amphetamines, barbiturates, cocaine, cannabis, hallucinogens within 12 months prior to Screening or positive urine drug screen at Screening or Day -1. A urine drug screen deemed positive due to prescription medications or for benzodiazepines or opioids is acceptable and inclusion is at the discretion of the Investigator;
  8. Regular use of alcohol within one month prior to the Screening visit (i.e. more than 10 units of alcohol per week or 4 units on any given day [1 unit = 150mL of wine, 260 mL of beer, or 45mL of 40% alcohol]);
  9. Symptomatic heart failure (per New York Heart Association [NYHA] guidelines), unstable angina, myocardial infarction, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to Screening;
  10. Has an abnormal ECG of clinical relevance at Screening or Baseline, including but not limited to the following:

    1. QTcF interval > 450 msec
    2. Evidence of 2nd and 3rd degree atrioventricular (AV) block, or 1st degree AV block with PR interval > 200ms, left bundle branch block (LBBB) or right bundle branch block (RBBB) at Screening or Baseline. Incomplete RBBB will not permitted.
    3. Has a history of risk factors including hypokalemia, family history of Long QT Syndrome, or prior use of medications that prolong the QT/QTc interval
  11. Has a resting heart rate < 45/minute, > 100/min upon one repeated measurement within 5 minutes;
  12. Has abnormal blood pressure outside specified limits (90 mm Hg > Systolic > 160 mm Hg and/or 50 mm Hg > Diastolic > 95 mm Hg) upon repeated measurement;
  13. Has clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Day -1 as determined by the Investigator;
  14. Has a history of malignancy within the last 2 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively treated malignancies who have no evidence of metastatic disease and more than a 2-year disease-free interval may be entered following approval by the Study Medical Monitor (MM);
  15. Has a history of major surgery within 6 months of Screening, OR has a history of minor surgery within the past month which would preclude inclusion as judged by the Investigator OR will not have fully recovered from surgery, OR has planned a surgery during the study;
  16. Has current or past allergic or adverse reaction or known sensitivity to olive oil, gelatin, glycerin and titanium dioxide, or to cannabinoid-like substances (Dronabinol/Marinol/Nabilone/marijuana/cannabis/tetrahydrocannabinol [THC], cannabinoid oil);
  17. Has known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or tests positive for any of these viruses at Screening;
  18. Use of the following in the 14 days prior to study drug administration or 5 half-lives, whichever is longer:

    1. Sedative medications (e.g., barbiturates and other central nervous system [CNS] depressants)
    2. Warfarin (Coumadin)
    3. Antipyrine
    4. Disulfiram (Antabuse)
    5. CYP3A4 inhibitors, inducers or substrates
    6. CYP2C9 inhibitors, inducers or substrates
    7. CYP2C19 inducers or substrates
    8. CYP2B6 substrates
    9. CYP1A2 substrates
    10. P-glycoprotein substrates

    Note: this includes grapefruit juice or related products, Sevilla orange juice or related products, and St John's wort.

  19. Unable to swallow an oral tablet/capsule (medication) or consume up to 300 mL of water within 30 minutes;
  20. Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest), or current participation in an investigational study, or participation in more than 4 investigational drug studies within 1 year prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867057


Contacts
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Contact: Mahsa Abrishami, Dr +1 (306) 651-7734 Mahsa.Abrishami@zyus.com
Contact: Adeline Makker +64 9307 4378 adeline.makker@novotech-cro.com

Locations
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Australia, South Australia
CMAX Clinical Research Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Paul Wabnitz, Dr         
Sponsors and Collaborators
ZYUS Life Sciences Inc.
Novotech (Australia) Pty Limited
ZYUS Life Sciences Australia Pty Ltd
Investigators
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Principal Investigator: Paul Wabnitz, Dr CMAX clinical research
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Responsible Party: ZYUS Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT04867057    
Other Study ID Numbers: Z-TRI-10001
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZYUS Life Sciences Inc.:
Osteoarthritis
OA
Chronic Pain
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases