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

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ClinicalTrials.gov Identifier: NCT01613040
Recruitment Status : Completed
First Posted : June 6, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Moxifloxacin Drug: RO4917838 Drug: RO4917838 placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : January 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment A Drug: RO4917838
Multiple daily low doses of RO4917838 for 10 days
Experimental: Treatment B Drug: RO4917838
Multiple daily oral high doses of RO4917838 for 10 days
Placebo Comparator: Treatment C Drug: Moxifloxacin
Single oral dose on Day 1
Drug: RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days
Placebo Comparator: Treatment D Drug: Moxifloxacin
Single oral dose on Day 11
Drug: RO4917838 placebo
Oral daily doses of placebo to RO4917838 for 10 days

Outcome Measures

Primary Outcome Measures :
  1. Changes in QTcF interval at steady state [ Time Frame: Baseline and Day 10 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613040

United States, Arizona
Tempe, Arizona, United States, 85283
Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01613040     History of Changes
Other Study ID Numbers: BP21705
2008-001127-57 ( EudraCT Number )
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors