A Clinical Trial of KDT-3594 to Evaluate the Drug-Drug Interaction with Itraconazole.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250055

Enrollment

Registered

2025-08-01

Start date

2025-09-01

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 disease

Interventions

1) Period I KDT-3594 will be administered as a single oral dose to the participants about one hour after the end of breakfast on Day 1. 2) Period II - Day 1-3: Itraconazole will be administered orally

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy Japanese male participants with a BMI of 18.5 kg/m2 to 25.0 kg/m2 and a body weight of 50 kg to less than 90 kg

Exclusion criteria

Exclusion criteria: Participants who have abnormal findings in medical examinations, vital signs, or 12-lead ECG, and are judged to be clinically significant by the principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Plasma pharmacokinetic profile of KDT-3594 (unchanged form)	—

Secondary

Measure	Time frame
- Plasma pharmacokinetic profile of metabolites of KDT-3594 - Incidence of adverse events and adverse drug reactions	—

Contacts

Public ContactYoshitaka Shimizu

Kissei Pharmaceutical Co., Ltd.

rinsyousiken@pharm.kissei.co.jp+81-3-5684-3533

Outcome results

None listed

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