Phase 1 Study of DS-3201b to Assess the Effects of Multiple Oral Administration of Rifampicin on the Pharmacokinetics of Single Oral Administration of DS-3201b Tablets in Healthy Japanese Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225242

Enrollment

Registered

2020-06-23

Start date

2020-07-29

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

Healthy volunteers

Interventions

investigational material(s) Generic name etc : DS-3201b INN of investigational material : valemetostat Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gender: Japanese males or females 2. Age: >=20 and ==18.5 and <25.0 (at screening)

Exclusion criteria

Exclusion criteria: 1. Having a history of hypersensitivity to any drugs or substances including rifampicin, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics - Pharmacokinetic parameters of plasma concentration of total DS-3201a: Cmax, AUClast, AUCinf	—

Secondary

Measure	Time frame
safety Pharmacokinetic: - Pharmacokinetic parameters of plasma concentration of total DS-3201a: Tmax, Kel, t1/2, CL/F, Vz/F - Pharmacokinetic parameters of plasma concentrations of unbound DS-3201a: Cmax, AUClast, AUCinf, Tmax, Kel, t1/2 - Pharmacokinetic parameters of plasma concentration of total CALZ-1809a: Cmax, AUClast, AUCinf, Tmax, Kel, t1/2 Safety: Adverse events, laboratory tests, body weight, vital signs (blood pressure, pulse rate, body temperature), and 12-lead electrocardiogram	—

Measure

Time frame

safety Pharmacokinetic: - Pharmacokinetic parameters of plasma concentration of total DS-3201a: Tmax, Kel, t1/2, CL/F, Vz/F - Pharmacokinetic parameters of plasma concentrations of unbound DS-3201a: Cmax, AUClast, AUCinf, Tmax, Kel, t1/2 - Pharmacokinetic parameters of plasma concentration of total CALZ-1809a: Cmax, AUClast, AUCinf, Tmax, Kel, t1/2 Safety: Adverse events, laboratory tests, body weight, vital signs (blood pressure, pulse rate, body temperature), and 12-lead electrocardiogram

—

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

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