Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease

NCT06212089 | Completed Phase 2

• 1 other identifier: TR-012001-PD201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to evaluate the safety and pharmacokinetics of TR-012001 in patients with Parkinson's disease when TR-012001 or placebo is administered.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (14)

• Safety evaluation of TR-012001: Incidents of Treatment-Emergent Adverse Events

  Name of adverse event, date and time of onset, severity, seriousness, outcome, date and time of outcome, and relationship to TR-012001 of all adverse events (including serious adverse events) are evaluated.

  Day of administration of TR-012001/placebo (Day3) to the day of leaving the facility (Day4). If any adverse event(s) continue or occur on Day4, follow-up will be conducted until recovery or until the investigator decides no longer follow-up is necessary.

• Safety evaluation of TR-012001: Incidents of physical findings

  The examination will include general findings and evaluation of the skin, eyes, ears/nose/throat, heart, chest, and abdomen. Record anything that is not normal, including those due to the subject's illness.

  4 days and 3 nights

• Safety evaluation of TR-012001: Vital sign (body temperature)

  The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

  4 days and 3 nights

• Safety evaluation of TR-012001: Vital sign (blood pressure)

  The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Blood pressure is measured in sitting state.

  4 days and 3 nights

• Safety evaluation of TR-012001: Vital sign (pulse rate)

  The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Pulse rate is measured in sitting state.

  4 days and 3 nights

• Safety evaluation of TR-012001: Columbia Suicide Severity Rating Scale (C-SSRS)

  To evaluate the safety and tolerability of TR-012001, Columbia-Suicide Severity Rating Scale (C-SSRS) (Japanese version) is used to evaluates suicidal ideation and behavior. Scale range: Yes or No response to 11 questions, with minimum to maximum range of 0 to 5. Lower score represents better outcomes. Subscales not applicable.

  Day 1 and Day 4

• Safety evaluation of TR-012001: Incidents of participants with laboratory abnormality

  The results of laboratory test values (hematological, blood biochemical, and urinary tests) will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

  Day 1 and Day 4

• Pharmacokinetics of TR-012001: Maximum plasma concentration (Cmax)

  Maximum observed plasma concentration of TR-012001.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Time to reach maximum plasma concentration (Tmax)

  Time to maximum observed plasma concentration of TR-012001.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Elimination half-life (t1/2)

  Elimination half-life.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Area under the plasma concentration-time curve (AUC0-inf)

  Area under the plasma concentration-time curve.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Mean residence time (MRT)

  Mean residence time.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Apparent whole body clearance (CL/f)

  Apparent whole body clearance.

  Pre-dose (baseline) and specified time points of post-dose

• Pharmacokinetics of TR-012001: Volume of distribution (Vd/f )

  Volume of distribution.

  Pre-dose (baseline) and specified time points of post-dose

Study Arms (2)

TR-012001

EXPERIMENTAL

Single dose of TR-012001

Drug: TR-012001

Placebo

OTHER

Single dose of placebo

Other: Placebo

Interventions

TR-012001 DRUG

A single dose of TR-012001 will be administered.

TR-012001

Placebo OTHER

A single dose of placebo will be administered.

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese males and females aged 30 years or older at the time of informed consent.
• Patients diagnosed with idiopathic Parkinson's disease according to the UKPDS Brain Bank Parkinson's disease diagnostic criteria.
• Patients with Parkinson's disease stage 2-4 on the modified Hoehn \& Yahr Scale in the "ON state".
• Patients who are taking levodopa-containing drugs\* three times or more per day, with a daily dosage of 300 mg or more of levodopa.
• \*Levodopa-containing drugs: Levodopa/dopa decarboxylase inhibitor (DCI) combination drugs; DCI can be either carbidopa or benserazide.
• Patients who can maintain a fixed dosage and administration of levodopa-containing drugs and other antiparkinsonian drugs (only for patients taking medication) after obtaining informed consent until the end of the study.
• Patients who are found to be OFF in their daily life by patient evaluation.
• Females of childbearing potential\*\* or males with female partners of childbearing potential\*\* who agree to practice adequate contraception on a daily basis from the time consent is obtained until the end of the study.
• \*\*Female (partners) of childbearing potential: Women who have not confirmed menopause (no menstruation for 52 weeks or more counting from the start of the last menstrual period).
• Patients who are fully informed about the purpose and contents of this study before the start of screening, who understand the contents of the informed consent form, and who can sign their own will.

You may not qualify if:

• Patients with non-idiopathic Parkinson's disease \[atypical Parkinson's disease, secondary (acquired or symptomatic) Parkinson's disease, Parkinson's plus syndrome, etc.\].
• Patients with hypersensitivity or allergy to the active pharmaceutical ingredient (API) or other ingredients used in the investigational drug, or patients with a history of severe allergy to other drugs (anaphylaxis, etc.).
• Patients with angle-closure glaucoma.
• Patients with disease or findings that are judged to affect this study from the viewpoint of safety and/or evaluation.
• Patients who received Levodopa-carbidopa continuous infusion gel therapy (LCIG therapy) or patients who plan to receive it during the study period.
• Patients who have used apomorphine subcutaneous injection 30 mg within 1 month prior to obtaining informed consent or patients who plan to use apomorphine during the study period.
• Patients who have undergone brain surgery for Parkinson's disease (pallidotomy, deep brain stimulation, etc.) or patients who plan to undergo such surgery during the study period.
• Patients who received or plan to receive transcranial magnetic stimulation therapy within 6 months prior to consent.
• Patients with a history or comorbidities of drug abuse or alcoholism.
• Patients with a history or comorbidities of mental illness (schizophrenia, psychotic depression, etc.). However, psychiatric symptoms associated with Parkinson's disease are excluded.
• Patients with overt dementia or Mini-Mental State Examination (MMSE) score less than 24 points.
• Patients with a history of suicidal ideation or attempted suicide within the past year or a history of present illness.
• Patients with a history of malignant syndrome caused by antiparkinsonian drugs.
• Patients with clinically problematic brain, cardiovascular, hematological, autoimmune, endocrine, cardiovascular, renal, gastrointestinal, or respiratory diseases (including infectious diseases) that are judged by the investigator to have the potential to affect the conduct of this study from the perspective of safety and other factors.
• Patients with any of the following laboratory test results from screening tests:

Sponsors & Collaborators

• SNLD, Ltd.: lead

Study Sites (1)

Saiseikai Imabari Hospital

Imabari, Ehime, 799-1592, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Akihisa Mori, PhD

  SNLD, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 18, 2024
• Study Start: September 28, 2023
• Primary Completion: April 26, 2024
• Study Completion: May 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)