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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01613040
First received: May 23, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This multiple-center, multiple-dose, randomized, double-blind, double-dummy, pla cebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteer s will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, A rm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Da y 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated tim e on study treatment is 11 days.


Condition Intervention Phase
Healthy Volunteer
Drug: Moxifloxacin
Drug: RO4917838
Drug: RO4917838 placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Changes in QTcF interval at steady state [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of electrocardiogram [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: No ]
  • Correlation of RO4917838 plasma concentration and the electrocardiogram [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
  • Change in the QTc interval, using moxifloxacin as an active control [ Time Frame: Days 1 and 11 ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the concentration time curve of RO4917838 [ Time Frame: Up to Day 19 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma concentration of RO4917838 [ Time Frame: Up to Day 19 ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613040

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

No publications provided by Hoffmann-La Roche

Additional 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
Study First Received: May 23, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014