NCT01521832

Escalating Dose Study in Healthy Volunteers With SEN0014196

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study Consisting of Single and Multiple Oral Dose Escalation to Determine, Safety, Tolerability and Pharmacokinetics of SEN0014196

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Siena Biotech S.p.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics of single and multiple escalating doses of SEN0014196.

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
DRUG	SEN0014196	5 mg single oral dose
DRUG	SEN0014196	25 mg single oral dose
DRUG	SEN0014196	75 mg single oral dose
DRUG	SEN0014196	150 mg single oral dose
DRUG	SEN0014196	300 mg single oral dose
DRUG	SEN0014196	600 mg single oral dose
DRUG	SEN0014196	300 mg single oral dose (females)
DRUG	SEN0014196	100 mg multiple oral dose
DRUG	SEN0014196	300 mg multiple oral dose
DRUG	SEN0014196	100 mg BID multiple oral dose
DRUG	SEN0014196	100 mg BID multiple oral dose (females)

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2012-01-31
• Last updated: 2012-02-07

Locations

1 site across 1 country: United Kingdom