NCT02564861

Multiple Dose Study of D1971a in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DS-1971a	DS 1971a is supplied as a powder or crystals and will be given as an oral suspension
DRUG	Placebo	Placebo matching DS-1971a suspension

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-10-01
• Last updated: 2017-04-28

Locations

1 site across 1 country: United Kingdom