Healthy Volunteer
Conditions
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.
Interventions
DRUGMoxifloxacin
Single oral dose on Day 1
DRUGRO4917838
Multiple daily low doses of RO4917838 for 10 days
DRUGRO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in QTcF interval at steady state | Baseline and Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change of electrocardiogram | Baseline and Day 10 |
| Pharmacokinetics: area under the concentration time curve of RO4917838 | Up to Day 19 |
| Pharmacokinetics: Maximum plasma concentration of RO4917838 | Up to Day 19 |
| Safety: incidence of adverse events | 8 weeks |
Countries
France, United States
Outcome results
None listed