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A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

NCT01209221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2016-11-02

No results posted yet for this study

Summary

This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Placebo - MAD

Once or twice daily doses of matching placebo to RO5271983 for 14 days

DRUG

Placebo - SAD

Single dose of matching placebo to RO5271983 for up to 3 periods

DRUG

RO5271983 - MAD

Once or twice daily doses of RO5271983 for 14 days

DRUG

RO5271983 - SAD

Single dose of RO5271983 at each period (for up to 3 periods)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Companies

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 NCT01209221 on ClinicalTrials.gov