ME-401 Clinical Pharmacology Study (Investigation of the Food Effect on the Pharmacokinetics of ME-401 in Healthy Japanese Adults)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200064

Enrollment

Registered

2020-12-10

Start date

2020-11-16

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

Japanese healthy adult males

Interventions

Food effect on the pharmacokinetics of ME-401 will be evaluated by using the crossover method of 2 groups x 2 periods. One capsule (60 mg/capsule) of the final formulation of ME-401 is administered in

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Personally provided written voluntary informed consent to participate in the study - Japanese men aged >= 20 and = 18.5 and < 25.0 kg/m2 at screening (the second decimal place is truncated)

Exclusion criteria

Exclusion criteria: - Current disease requiring treatment - History of or current digestive system diseases (peptic ulcer, reflux esophagitis, etc.) excluding history of appendicitis - Current allergic disease with symptoms or on treatment at screening

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic - Ratios of geometric mean values of Cmax, AUC0-t, AUC0-inf between fed state and fasted state	—

Secondary

Measure	Time frame
- Pharmacokinetic - Pharmacokinetic parameters - Plasma ME-401 concentrations - Safety - Adverse events - Laboratory test values - Vital signs - Standard 12-lead electrocardiograms	—

Contacts

Public ContactClinical trial information contact

Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com+81-90-9975-7702

Outcome results

None listed

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