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A Phase 1 Study of ONO-2020 in Healthy Participants

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: NCT05507515
Recruitment Status : Completed
First Posted : August 19, 2022
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Tracking Information
First Submitted Date  ICMJE August 11, 2022
First Posted Date  ICMJE August 19, 2022
Last Update Posted Date April 9, 2024
Actual Study Start Date  ICMJE July 29, 2022
Actual Primary Completion Date December 24, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2023)
  • Incidence, severity, and type of treatment emergent adverse events (TEAEs) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Incidence of TEAEs will be summarized overall, and by study part and dose group using frequency and percentage.
  • Vital signs (blood pressure) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (pulse rate) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (body temperature) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (respiratory rate) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • 12-lead electrocardiograms (ECGs) parameters, such as but not limited to heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of ECG results will be tabulated at each time point.
  • Clinically significant abnormal telemetry electrocardiograms (ECGs) [ Time Frame: Part A and D: Day 1 ]
    The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of telemetry ECGs results will be tabulated at each time point.
  • Clinically significant abnormal physical examination findings [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of physical examination results will be tabulated at each time point.
  • Clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    The number and percentage of subjects with abnormal laboratory results at any time during the study will be tabulated.
  • Ophthalmologic examination findings (pupil size and pupillary light reflex) [ Time Frame: Part A, C and D: From Day 1 up to Day 7, Part B and E: From Day 1 up to Day 21 ]
    The number and percentage of subjects with miosis will be summarized by laterality at each time point.
  • Clinically abnormal findings in Mini-International Neuropsychiatric Interview Screen (M.I.N.I.-Screen) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Responses to the M.I.N.I.-Screen will be listed.
  • Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Responses to the suicidality assessment scale (C-SSRS) will be listed.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
  • Incidence, severity, and type of treatment emergent adverse events (TEAEs) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Incidence of TEAEs will be summarized overall, and by study part and dose group using frequency and percentage.
  • Vital signs (blood pressure) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (pulse rate) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (body temperature) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Vital signs (respiratory rate) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • 12-lead electrocardiograms (ECGs) parameters, such as but not limited to heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Clinically significant abnormal telemetry electrocardiograms (ECGs) [ Time Frame: Part A and D: Day 1 ]
    The number and percentage of subjects with normal, abnormal not clinically significant and abnormal clinically significant of telemetry ECGs results will be tabulated at each time point.
  • Clinically significant abnormal physical examination findings [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Observed values and change from baseline results will be summarized by analysis time point, and summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.
  • Clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    The number and percentage of subjects with abnormal laboratory results at any time during the study will be tabulated.
  • Ophthalmologic examination findings (pupil size and pupillary light reflex) [ Time Frame: Part A, C and D: From Day 1 up to Day 7, Part B and E: From Day 1 up to Day 21 ]
    The number and percentage of subjects with miosis will be summarized by laterality at each time point.
  • Clinically abnormal findings in Mini-International Neuropsychiatric Interview Screen (M.I.N.I.-Screen) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Responses to the M.I.N.I.-Screen will be listed.
  • Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Part A, C and D: From screening up to Day 7, Part B and E: From screening up to Day 21 ]
    Responses to the suicidality assessment scale (C-SSRS) will be listed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
  • Pharmacokinetics (Cmax in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (Tmax in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (AUClast in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (AUCinf in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (T1/2 in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (CL/F in plasma) [ Time Frame: Part A, C and D: Day 1 through Day 4, Part B and E: Day 1 through Day 19 ]
  • Pharmacokinetics (Aet in urine) [ Time Frame: Part A and D: Day 1 through Day 4 ]
  • Pharmacokinetics (fe/F in urine) [ Time Frame: Part A and D: Day 1 through Day 4 ]
  • Pharmacokinetics (CLR in urine) [ Time Frame: Part A and D: Day 1 through Day 4 ]
  • Pharmacokinetics (Ctrough in plasma) [ Time Frame: Part B and E: Day 2 through Day 13 ]
  • Pharmacokinetics (ONO-2020 concentration in CSF) [ Time Frame: Part C: Day 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of ONO-2020 in Healthy Participants
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Five-part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of ONO-2020 in Healthy Participants
Brief Summary The purpose of this FIH study is to evaluate the safety, tolerability and pharmacokinetics of ONO-2020 in healthy adult participants. This FIH study consists of five parts (Parts A-E) to study single or multiple doses of ONO-2020 in healthy participants, including elderly and Japanese participants, as well as the food effect on the PK of ONO-2020. These data will support the clinical development program and help inform dose selection in future studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: ONO-2020
    ONO-2020 tablets
  • Drug: Placebo
    Placebo tablets matching ONO-2020 tablets
Study Arms  ICMJE
  • Experimental: Part A: Cohort A1 ONO-2020 or Placebo - fasted
    Single ascending doses of ONO-2020 orally under fasted conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part A: Cohort A2 ONO-2020 or Placebo - fasted and fed
    Single ascending doses of ONO-2020 orally under fasted and fed conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part A: Cohort A3 ONO-2020 or Placebo - fasted
    Single ascending doses of ONO-2020 orally under fasted conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part A: Cohort A4 ONO-2020 or Placebo - fasted and fed
    Single ascending doses of ONO-2020 orally under fasted and fed conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part A: Cohort A5 ONO-2020 or Placebo - fasted
    Single ascending doses of ONO-2020 orally under fasted conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part A: Cohort A6 ONO-2020 or Placebo - fasted
    Single ascending doses of ONO-2020 orally under fasted conditions
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part B: Cohort B1 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part B: Cohort B2 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part B: Cohort B3 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part B: Cohort B4 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part B: Cohort B5 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part C: Cohort C1 ONO-2020
    Single dose of ONO-2020 orally for CSF sampling
    Intervention: Drug: ONO-2020
  • Experimental: Part C: Cohort C2 ONO-2020
    Single dose of ONO-2020 orally for CSF sampling
    Intervention: Drug: ONO-2020
  • Experimental: Part D: Cohort D1 ONO-2020 or Placebo
    Single dose of ONO-2020 orally in elderly healthy volunteers
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part E: Cohort E1 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
  • Experimental: Part E: Cohort E2 ONO-2020 or Placebo
    Multiple ascending doses of ONO-2020 orally for 14 days in Japanese healthy volunteers
    Interventions:
    • Drug: ONO-2020
    • Drug: Placebo
Publications * Not Provided

*   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: February 20, 2024)		 132
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2022)		 138
Actual Study Completion Date  ICMJE December 24, 2023
Actual Primary Completion Date December 24, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 to 55 years of age (Parts A, B, C, and E) or ≥65 years of age (Part D) inclusive at the time of informed consent.
  2. Male and female participants of non-Japanese ethnicity (Parts A, B, C, and D) or of Japanese ethnicity (Part E).
  3. No clinically significant medical history and no abnormal physical examination, laboratory profiles, vital signs or ECG abnormalities, based on the Screening examination.
  4. Body mass index of ≥18.5 to <30 kg/m2, and a body weight of at least 50 kg for males and 45 kg for females to a maximum of 100 kg, at the time of Screening.
  5. Agree to use an effective method of contraception.
  6. Able and willing to give informed consent after reading the information and consent form and after having the opportunity to discuss the study with the Investigator or designee.
  7. Estimated creatinine clearance (CrCL, Cockcroft-Gault equation) ≥90 mL/min at Screening. In Part D only, an estimated ≥60 mL/min at Screening.
  8. Fully vaccinated for SARS-CoV-2 (received primary series of COVID-19 vaccine) prior to Screening.

Exclusion Criteria:

  1. Mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
  2. History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the Investigator or Sponsor Medical Monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study.
  3. hypersensitivity or idiosyncratic reaction to the study interventions, excipients or related compounds, or severe food allergies.
  4. alcoholism or drug/chemical/substance abuse within the past 2 years prior to the first dosing.
  5. Use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements, including St. John's Wort, within 14 days or five half-lives (whichever is longer) of first dosing and throughout the study.
  6. Use of any drugs known to be significant inducers or inhibitors of cytochrome P450 (CYP) enzymes and/or drug transporter substrates for 28 days prior to the first dosing and throughout the study.
  7. Participation in another clinical study within 120 days (or five half-lives of the study intervention, whichever is longer) prior to the first dosing.
  8. Liver function test values are in the abnormal range before inclusion.
  9. Positive urine drug, alcohol, or cotinine results at Screening or check in.
  10. Positive results at Screening for active viral infection that include HIV, HBV, HCV, and SARS-CoV-2.
  11. Seated resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
  12. Seated resting pulse rate is lower than 40 beats per minute (bpm) or higher than 100 bpm at Screening.
  13. Clinically significant history or presence of ECG findings.
  14. The participant is a current smoker or has smoked within 3 months of Screening or has a positive urine cotinine at Screening or admission.
  15. Female who is pregnant or lactating.
  16. Donation of blood or significant blood loss of 400 mL or more within 90 days prior to the first dosing, or blood donation of 200 mL or more within 30 days prior to the first dosing, or blood plasma or platelet donation within 14 days prior to the first dosing, or blood transfusion within 90 days prior to the first dosing.

  17. Participants who, in the opinion of the Investigator, are considered unsuitable for any other reason.

    Exclusion criteria, applicable to all participants taking part in the food effect Cohort in Part A:

  18. Participants who are vegetarian or vegan or not willing to eat a high-fat breakfast.

    Exclusion criteria, applicable to all participants undergoing lumbar puncture for CSF collection (Part C):

  19. History of significant back pain, significant kyphosis, and or scoliosis or other spinal column deformities.
  20. History of poor venous access.
  21. History of hypersensitivity for local anesthetics (Lidocaine).
  22. History or evidence or fundoscopic findings suggestive of raised intracranial pressure.
  23. History or evidence of laboratory abnormalities for coagulation parameters or the use of medications that may increase the risk of bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05507515
Other Study ID Numbers  ICMJE ONO-2020-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ono Pharmaceutical Co. Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Project Leader Ono Pharma USA Inc
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date April 2024

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