NCT01613040

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

May 23, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Changes in QTcF interval at steady state

    Baseline and Day 10

Secondary Outcomes (6)

  • Change of electrocardiogram

    Baseline and Day 10

  • Correlation of RO4917838 plasma concentration and the electrocardiogram

    Day 10

  • Change in the QTc interval, using moxifloxacin as an active control

    Days 1 and 11

  • Safety: incidence of adverse events

    8 weeks

  • Pharmacokinetics: area under the concentration time curve of RO4917838

    Up to Day 19

  • +1 more secondary outcomes

Study Arms (4)

Treatment A

EXPERIMENTAL
Drug: RO4917838

Treatment B

EXPERIMENTAL
Drug: RO4917838

Treatment C

PLACEBO COMPARATOR
Drug: MoxifloxacinDrug: RO4917838 placebo

Treatment D

PLACEBO COMPARATOR
Drug: MoxifloxacinDrug: RO4917838 placebo

Interventions

MoxifloxacinDRUG

Single oral dose on Day 1

Treatment C
RO4917838DRUG

Multiple daily low doses of RO4917838 for 10 days

Treatment A
RO4917838 placeboDRUG

Oral daily doses of placebo to RO4917838 for 10 days

Treatment CTreatment D

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male volunteers aged 18 to 65 years inclusive
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
  • Have no contraindications from the following: a detailed medical and surgical history, and a complete physical examination
  • Able to participate, and willing to give written informed consent and to comply with the study restrictions

You may not qualify if:

  • History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, mental, cardiac, vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
  • History of alcohol and/or drug abuse or addiction within the last 2 years prior to Day 1 of the study.
  • Consumption of nicotine and/or tobacco containing products within the last 3 months prior to Day 1 of the study.
  • Infection with human immunodeficiency virus, hepatitis B and/or hepatitis C
  • Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
  • Positive drug screen or alcohol test at screening or prior to enrollment.
  • Coffee or tea consumption \> 10 cups per day or methylxanthine containing drinks \>1.5 liter/day or more than 250 g/day of chocolate.
  • Alcohol consumption averaging \> 3 drinks daily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Tempe, Arizona, 85283, United States

Location

Unknown Facility

Strasbourg, 67064, France

Location

Related Publications (1)

  • Hofmann C, Banken L, Hahn M, Swearingen D, Nagel S, Martin-Facklam M. Evaluation of the effects of bitopertin (RG1678) on cardiac repolarization: a thorough corrected QT study in healthy male volunteers. Clin Ther. 2012 Oct;34(10):2061-71. doi: 10.1016/j.clinthera.2012.08.010. Epub 2012 Sep 12.

    PMID: 22980315DERIVED

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

June 6, 2012

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)FR(1)