Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200043

Enrollment

Registered

2020-10-13

Start date

2020-10-31

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

Healthy subjects

Interventions

Oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gender: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, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.

Design outcomes

Primary

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

Secondary

Measure	Time frame
PK: Plasma PK parameters for DS-3201a (total and unbound concentrations) Safety: AEs, laboratory data, body weight, vital signs, and 12-lead ECGs	—

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: Feb 4, 2026