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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ketoconazole

Drug: RO4602522

Study type

Interventional

Funder types

Industry

Identifiers

NCT01625806

2012-001195-11 (EudraCT Number)

BP28236

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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