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A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

NCT ID: NCT01967979

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.

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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Cohort 1 (Itraconazole DDI)

Group Type EXPERIMENTAL

RO5285119

Intervention Type DRUG

Single dose, alone and after repeated administration of itraconazole or fluoxetine

itraconazole

Intervention Type DRUG

Multiple doses

Cohort 2 (Fluoxetine DDI)

Group Type EXPERIMENTAL

RO5285119

Intervention Type DRUG

Single dose, alone and after repeated administration of itraconazole or fluoxetine

fluoxetine

Intervention Type DRUG

Multiple doses

Interventions

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RO5285119

Single dose, alone and after repeated administration of itraconazole or fluoxetine

Intervention Type DRUG

fluoxetine

Multiple doses

Intervention Type DRUG

itraconazole

Multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects, 18 to 55 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination
* Body mass index (BMI) between 18 to 30 kg/m2 inclusive
* Women must be postmenopausal (for at least 12 months of amenorrhea confirmed by FSH, or for at least 24 months if on hormone replacement therapy) or surgically sterile (absence of ovaries and/or uterus)
* For men with a female partner of child-bearing potential: agreement to use a barrier method of contraception during the treatment period and for at least 3 months after the last dose of study drug

Exclusion Criteria

* Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
* Positive for hepatitis B, hepatitis C , or HIV infection
* Participation in an investigational drug or device study within 90 days prior to first dosing
* 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
* Hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal, or any other known contraindications to itraconazole as stated in the SmPC
* Hypersensitivity to fluoxetine or to any of the other ingredients, or any other known contraindications to fluoxetine as stated in the SmPC
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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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2013-003232-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28977

Identifier Type: -

Identifier Source: org_study_id