NCT02647307

Study of the Effects of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of DS-1040b

A Phase I, Open Label, Parallel Group Study to Evaluate the Effect of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of a DS 1040b IV Infusion Administered to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The proposed study is not hypothesis testing but is intended to explore the effects of different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b. Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety \& tolerability.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DS-1040b	Single 12-hour intravenous infusion of DS-1040b (20 mg)

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-01-06
• Last updated: 2018-12-24

Locations

1 site across 1 country: United Kingdom