A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

NCT03830528 | Completed Phase 1

• 1 other identifier: 6356-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• Part A Number and percentage of subjects with treatment-emergent adverse events

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

• Part B Number and percentage of subjects with treatment-emergent adverse events

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

• Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

Secondary Outcomes (3)

• Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

• Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

• Part C Number and percentage of subjects with treatment-emergent adverse events

  Starting about 24 hours before dosing and continued until about 7-14 days after last dose

Study Arms (7)

Part A-1

EXPERIMENTAL

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

Drug: KW-6356 Low Dose

Part A-2

EXPERIMENTAL

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

Drug: KW-6356 Middle Dose

Part A-3

EXPERIMENTAL

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

Drug: KW-6356 High Dose

Part B

EXPERIMENTAL

There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo)

Drug: KW-6356 X Dose

Part C-1

EXPERIMENTAL

There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)

Drug: KW-6356 Y Dose

Part C-2

EXPERIMENTAL

There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)

Drug: KW-6356 Y Dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KW-6356 Low Dose DRUG

KW-6356 will be administered as single doses.

Part A-1

KW-6356 Middle Dose DRUG

KW-6356 will be administered as single doses.

Part A-2

KW-6356 High Dose DRUG

KW-6356 will be administered as single doses.

Part A-3

KW-6356 X Dose DRUG

KW-6356 will be administered as multiple doses.

Part B

KW-6356 Y Dose DRUG

KW-6356 will be administered for Japanese healthy men as multiple doses.

Part C-1; Part C-2

Placebo DRUG

All study cohorts (except Part C) are placebo controlled.

Placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who provided freely-given written consent for participating in this study
• Men aged 20 ≥ and \< 45 at the time of informed consent;
• Japanese individuals without mixed marriage for at least last two generations, for participating Part A and Part B
• Japanese and Caucasian individuals without mixed marriage for at least last two generations, for participating Part C
• Individuals with BMI ≥ 18.5 and \< 30.0
• Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg

You may not qualify if:

• Individuals with any current diseases requiring treatment
• Individuals with current cerebrovascular, gastrointestinal, cardiovascular, hematologic, renal, or liver diseases
• Individuals with current symptomatic allergy
• Individuals with current or past drug allergy
• Individuals with current or past psychiatric disorders
• Individuals with a history of any autoimmune diseases or malignant tumor
• Individuals with alcohol or drug dependence, or those who showed any positive result(s) in drug abuse tests
• Individuals with a history of congestive heart failure, hypokalemia, hypocalcemia, or QT prolongation syndrome
• Individuals with positive result in any of viral infection tests (HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen and antibody, and HTLV-1 antibody) or syphilis tests (RPR and TP antibody) at screening.
• Individuals with abnormality in standard 12-lead ECG that the investigator or subinvestigator determined as clinically significant at screening, Day -1, and before administration of the study drug on Day 1.
• Individuals who participated in clinical trial(s) of any medical products and received administration of those within 4 months prior to the study drug administration in the current study
• Individuals who used drugs (including non-prescription drugs, external preparation, vitamins, health supplements, and herbal medicines) within 2 weeks prior to the study drug administration
• Individuals who consumed grapefruit, or any food and beverage containing grapefruit or St John's Wort within 1 week prior to the study drug administration
• Individuals who smoked or used stop-smoking aid products (including chewing or eating nicotine-containing products, or application of nicotine patches) within 4 weeks prior to the study drug administration
• Individuals who admitted to the hospital or had surgery within 3 months prior to the study drug administration

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Medical Co. LTA Sumida Hospital

Tokyo, Japan

Location

Related Publications (1)

• Tayama T, Ishiuchi M, Sugiyama K, Oka Y, Maeda H, Nagata Y, Hruska M, Kagawa Y. Safety, Tolerability, and Pharmacokinetics of the Novel Adenosine A2A Antagonist/Inverse Agonist KW-6356 Following Single and Multiple Oral Administration in Healthy Volunteers. Clin Pharmacol Drug Dev. 2023 Aug;12(8):801-809. doi: 10.1002/cpdd.1222. Epub 2023 Jan 22.

  PMID: 36683291 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 5, 2019
• Study Start: February 26, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

JP (1)