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Completed

NCT Number: NCT01625806

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

RO4602522

Drug

Single oral dose

Ketoconazole

Drug

Multiple oral doses

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 21, 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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