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Phase 1 study of DS-3201b to evaluate the pharmacokinetics and safety after single oral administration, the relative bioavailability after administration of tablet and capsule formulations, and the effect of food on the pharmacokinetics in healthy Japanese subjects

Phase 1 study of DS-3201b to evaluate the pharmacokinetics and safety after single oral administration, the relative bioavailability after administration of tablet and capsule formulations, and the effect of food on the pharmacokinetics in healthy Japanese subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223748
Enrollment
50
Registered
2017-12-11
Start date
2017-12-14
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 : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

DAIICHI SANKYO CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Part 1 & 2 1.Having a history of hypersensitivity to drugs or other substances or being idiosyncratic (eg, having penicillin allergy) 2.Having alcohol or drug dependence

Design outcomes

Primary

MeasureTime frame
Part 1: Safety, Part 2: Pharmacokinetics—

Secondary

MeasureTime frame
Part 1: Pharmacokinetics, Part 2: Safety—

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

+81-3-6225-1111

Outcome results

None listed

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