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A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers

NCT01613040 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2016-11-02

No results posted yet for this study

Summary

This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Moxifloxacin

Single oral dose on Day 1

DRUG

Moxifloxacin

Single oral dose on Day 11

DRUG

RO4917838

Multiple daily low doses of RO4917838 for 10 days

DRUG

RO4917838

Multiple daily oral high doses of RO4917838 for 10 days

DRUG

RO4917838 placebo

Oral daily doses of placebo to RO4917838 for 10 days

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • France

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 NCT01613040 on ClinicalTrials.gov