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Escalating Dose Study in Healthy Volunteers With SEN0014196

NCT01521832 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2012-02-07

No results posted yet for this study

Summary

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • Siena Biotech S.p.A.

    lead INDUSTRY

Principal Investigators

  • Joseph A Chiesa, MD · Covance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01521832 on ClinicalTrials.gov