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

NCT ID: NCT03830528

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2019-10-10

Brief Summary

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

Detailed Description

The study will have 3 parts:

• In Part A and Part B, a placebo-controlled double-blind study will be conducted to investigate safety, tolerability and pharmacokinetics of a single dose and 14 days multiple doses of KW-6356 in Japanese healthy men, respectively
• In Part C, an open-label study will be conducted to investigate safety, tolerability and pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy men

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A-1

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

Group Type: EXPERIMENTAL

KW-6356 Low Dose

Intervention Type: DRUG

KW-6356 will be administered as single doses.

Part A-2

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

Group Type: EXPERIMENTAL

KW-6356 Middle Dose

Intervention Type: DRUG

KW-6356 will be administered as single doses.

Part A-3

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

Group Type: EXPERIMENTAL

KW-6356 High Dose

Intervention Type: DRUG

KW-6356 will be administered as single doses.

Part B

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)

Group Type: EXPERIMENTAL

KW-6356 X Dose

Intervention Type: DRUG

KW-6356 will be administered as multiple doses.

Part C-1

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)

Group Type: EXPERIMENTAL

KW-6356 Y Dose

Intervention Type: DRUG

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

Part C-2

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)

Group Type: EXPERIMENTAL

KW-6356 Y Dose

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

KW-6356 Low Dose

KW-6356 will be administered as single doses.

Intervention Type: DRUG

KW-6356 Middle Dose

KW-6356 will be administered as single doses.

Intervention Type: DRUG

KW-6356 High Dose

KW-6356 will be administered as single doses.

Intervention Type: DRUG

KW-6356 X Dose

KW-6356 will be administered as multiple doses.

Intervention Type: DRUG

KW-6356 Y Dose

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Individuals who had any of the following blood drawing for donation, clinical trial, or any other reasons prior to the study drug administration; ≥ 400 mL blood collection within 3 months; ≥ 200 mL blood collection within 4 weeks; or blood collection for pheresis (such as plasmapheresis or plateletpheresis) donation, clinical trial, or any other reasons within 2 weeks
• Individuals who did not agree to use appropriate contraceptive measures from the day of admission to 12 weeks after the last administration of study drug. The appropriate contraceptive measures are defined as refraining from sexual activity or combining two contraceptive methods including condom, oral contraceptives, intrauterine contraceptive devices or pessary.
• Any other individuals who were determined as not suitable for participating in this study by the investigator or subinvestigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Co. LTA Sumida Hospital

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 36683291 (View on PubMed)

Other Identifiers

6356-004

Identifier Type: -

Identifier Source: org_study_id