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

NCT ID: NCT01625806

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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RO4602522

Group Type ACTIVE_COMPARATOR

RO4602522

Intervention Type DRUG

Single oral dose

RO4602522 + ketoconazole

Group Type EXPERIMENTAL

RO4602522

Intervention Type DRUG

Single oral dose

ketoconazole

Intervention Type DRUG

Multiple oral doses

Interventions

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RO4602522

Single oral dose

Intervention Type DRUG

ketoconazole

Multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012-001195-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28236

Identifier Type: -

Identifier Source: org_study_id