Zuidlaren, 9471 GP, Netherlands
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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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugSingle oral dose
Ketoconazole
DrugMultiple oral doses
Primary outcomes
-
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
-
Safety: Incidence of adverse events
Time frame: approximately 3 months
-
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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