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Completed

NCT Number: NCT01613040

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Strasbourg, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin

Drug

Single oral dose on Day 1

RO4917838

Drug

Multiple daily low doses of RO4917838 for 10 days

RO4917838 placebo

Drug

Oral daily doses of placebo to RO4917838 for 10 days

Primary outcomes

  1. Changes in QTcF interval at steady state

    Time frame: Baseline and Day 10

Secondary outcomes

  1. Change of electrocardiogram

    Time frame: Baseline and Day 10

  2. Correlation of RO4917838 plasma concentration and the electrocardiogram

    Time frame: Day 10

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

    Time frame: Days 1 and 11

  4. Safety: incidence of adverse events

    Time frame: 8 weeks

  5. Pharmacokinetics: area under the concentration time curve of RO4917838

    Time frame: Up to Day 19

  6. Pharmacokinetics: Maximum plasma concentration of RO4917838

    Time frame: Up to Day 19

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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