drugset / Trial / NCT02107885

Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.

NCT02107885

Phase 1 Completed 64 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindBasic science

Summary

This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is hypothesised that single oral doses of DS-1971a within the planned dose range will be safe and well tolerated by healthy male subjects.

Timeline

Start
2014-03
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject DS-1971 Small molecule 5 mg Oral
Subject DS-1971 Small molecule 10 mg Oral
Subject DS-1971 Small molecule 30 mg Oral
Subject DS-1971 Small molecule 90 mg Oral
Subject DS-1971 Small molecule 250 mg Oral
Subject DS-1971 Small molecule 500 mg Oral
Subject DS-1971 Small molecule 1000 mg Oral
Subject DS-1971 Small molecule 1500 mg Oral

Indications

No indication recorded.