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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01625806
First received: June 19, 2012
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: RO4602522
Drug: ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]
  • RO4602522 metabolites: Plasma/urine concentrations [ Time Frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RO4602522 Drug: RO4602522
Single oral dose
Experimental: RO4602522 + ketoconazole Drug: RO4602522
Single oral dose
Drug: ketoconazole
Multiple oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01625806

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01625806     History of Changes
Other Study ID Numbers: BP28236, 2012-001195-11
Study First Received: June 19, 2012
Last Updated: May 7, 2013
Health Authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014