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

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613040
• Other study ID #: BP21705
• Secondary ID: 2008-001127-57
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: November 1, 2016
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Moxifloxacin
Single oral dose on Day 1
• Moxifloxacin
Single oral dose on Day 11
• RO4917838
Multiple daily low doses of RO4917838 for 10 days
• RO4917838
Multiple daily oral high doses of RO4917838 for 10 days
• RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in QTcF interval at steady state		Baseline and Day 10	No
Secondary	Change of electrocardiogram		Baseline and Day 10	No
Secondary	Correlation of RO4917838 plasma concentration and the electrocardiogram		Day 10	No
Secondary	Change in the QTc interval, using moxifloxacin as an active control		Days 1 and 11	No
Secondary	Safety: incidence of adverse events		8 weeks	No
Secondary	Pharmacokinetics: area under the concentration time curve of RO4917838		Up to Day 19	No
Secondary	Pharmacokinetics: Maximum plasma concentration of RO4917838		Up to Day 19	No