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Multiple Dose Study of D1971a in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Phase I, Double-Blind, Randomised, Placebo Controlled, Multiple-Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male and Female Subjects

Clinical Trial Summary

This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male and female subjects. Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula.

Clinical Trial Description

Within strictly defined limits, the protocol permits the dose escalation committee to amend the dose escalation rules, doses proposed in the study protocol and to change the timing of or to add additional assessments following review of the safety, tolerability and plasma DS-1971a concentration data. The decisions to change the doses will be documented in the minutes of the dose escalation committee. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02564861
Study type Interventional
Source Daiichi Sankyo Inc.
Contact
Status Completed
Phase Phase 1
Start date September 2015
Completion date December 2015
View Details
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