Back to Parkinsons Disease
NCT04070495
NCT04070495
Who may be able to join
Who might be able to join this trial:
- You are willing to give written consent to take part in this study voluntarily
- You are a Japanese man aged between 20 and 44 years old at the time of signing the consent form
- Your Body Mass Index (BMI) — a measure of body weight relative to height — is between 18.5 and 24.9 at the screening visit
- Your resting heart rate is between 40 and 100 beats per minute, and your blood pressure readings fall within specific healthy ranges at screening (confirm with trial site)
Who may not be able to join:
- You currently have any illness or condition that requires medical treatment
- You have had a drug allergy at any point in your life
- You have had or currently have any psychiatric or mental health condition
- You tested positive for any of the following infections during screening: Hepatitis B, Hepatitis C, HIV, HTLV-1, syphilis, or certain related markers (confirm with trial site)
- You have a clinically significant abnormality shown on a heart tracing (ECG) recorded before the study starts
- You fall into a category of patients for whom the study drug's official warnings or contraindications apply (confirm with trial site)
- You have taken any medication — including over-the-counter medicines, vitamins, supplements, skin treatments, or herbal remedies — within 2 weeks before the study drug is first given
- You have eaten or drunk anything containing grapefruit or St John's Wort within 1 week before the study drug is first given
- You have smoked, used nicotine products (such as patches, chewing tobacco, or nicotine gum), or used stop-smoking aids within 4 weeks before the study drug is first given
- You have been admitted to hospital or had surgery within 12 weeks before the study drug is first given
- You have taken part in another clinical trial involving a drug or medical device within 4 months before the study drug is first given
- You have donated 400 mL or more of blood in the last 12 weeks, 200 mL or more in the last 4 weeks, or donated platelets or plasma in the last 2 weeks before the study drug is first given
- You are not willing to use appropriate contraception from the time you are admitted until 12 weeks after the last dose of the study drug (confirm with trial site for accepted methods)
- You have previously received the study drug KW-6356
- The study doctor considers you unsuitable to take part for any other reason
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 1
Sponsor
Kyowa Kirin Co., Ltd.
Registry
clinicaltrials_gov
Start date
27 August 2019
Est. completion
19 November 2019
Where this trial is recruiting
🇯🇵 Japan
Primary endpoints
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.