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A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625806
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO4602522 Drug: ketoconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects
Study Start Date : July 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: RO4602522 Drug: RO4602522
Single oral dose

Experimental: RO4602522 + ketoconazole Drug: RO4602522
Single oral dose

Drug: ketoconazole
Multiple oral doses

Primary Outcome Measures :
  1. Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22 ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 months ]
  2. RO4602522 metabolites: Plasma/urine concentrations [ Time Frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects, 18 to 45 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Male subjects and their partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 90 days after the last dose
  • Non-smoker (not having smoked since at least 3 months prior to screening)

Exclusion Criteria:

  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
  • Positive for hepatitis B, hepatitis C, or HIV infection
  • Participation in an investigational drug or device study within 90 days prior to screening
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • History of any disease or condition that could alter the absorption, metabolism or elimination of drugs
  • Positive drug test and/or positive alcohol test
  • Positive cotinine test
  • Subject likely to need concomitant medication during the study period (including for dental conditions)
  • Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator

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 identifier (NCT number): NCT01625806

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Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01625806     History of Changes
Other Study ID Numbers: BP28236
2012-001195-11 ( EudraCT Number )
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors