A Phase 1 Clinical Trial of Olutasidenib in Japanese and Caucasian Healthy Adult Males

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250348

Enrollment

Registered

2025-09-18

Start date

2025-10-16

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

Acute Myeloid Leukemia

Interventions

Ortasidenib will be administered orally as a single dose to subjects in the fasting state.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy Japanese or Caucasian male participants with a BMI of 18.5 kg/m2 or higher and less than 30 kg/m2 and a body weight of 50 kg or more and less than 90 kg

Exclusion criteria

Exclusion criteria: Participants who have any abnormal finding in medical examination, vital signs, or 12-lead ECG, which is considered by the principal investigator or subinvestigator to be clinically significant

Design outcomes

Primary

Measure	Time frame
Plasma concentrations and pharmacokinetic profile of olutasidenib	—

Secondary

Measure	Time frame
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