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A Phase 1 Study of KK6483 in Healthy Male Volunteers

A Phase 1 Study of KK6483 in Healthy Male Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051200104
Enrollment
40
Registered
2020-12-24
Start date
2021-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET)

Sponsors

Yagi Michio
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Those who have provided voluntary written consent to participate in the study 2) Men aged >= 20 to = 18.5 to < 25.0 at the time of preliminary test

Exclusion criteria

Exclusion criteria: 1) Those with present illness requiring treatment 2) Those with a history of or current drug allergy 3) Those currently having respiratory disease, heart disease, gastrointestinal disease, renal disease, or hepatic disease 4) Those with a history of or current psychiatric disease 5) Those currently having clinically significant orthostatic hypotension 6) Those who have had a bacterial, viral, fungal, or parasitic infection within 28 days prior to signing the informed consent

Design outcomes

Primary

MeasureTime frame
Plasma drug concentration Pharmacokinetic parameters

Contacts

Public ContactClinical trial information contact

Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com+81-3-5205-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026