Clinical trial NCT01613040: A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers
Official title: A Multiple-center, Multiple-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Parallel Group Study to Investigate the Effect of RO4917838 on the QTc Interval in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 169
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in QTcF interval at steady state
timeFrame: Baseline and Day 10
Secondary outcomes:
measure: Change of electrocardiogram
timeFrame: Baseline and Day 10
measure: Correlation of RO4917838 plasma concentration and the electrocardiogram
timeFrame: Day 10
measure: Change in the QTc interval, using moxifloxacin as an active control
timeFrame: Days 1 and 11
measure: Safety: incidence of adverse events
timeFrame: 8 weeks
measure: Pharmacokinetics: area under the concentration time curve of RO4917838
timeFrame: Up to Day 19
measure: Pharmacokinetics: Maximum plasma concentration of RO4917838
timeFrame: Up to Day 19
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.