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A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819

NCT ID: NCT01409369

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-02-29

Brief Summary

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This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.

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

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RO4995819

Intervention Type DRUG

single oral dose

activated charcoal

Intervention Type DRUG

orally 3 times daily, Days 1-7

2

Group Type ACTIVE_COMPARATOR

RO4995819

Intervention Type DRUG

single oral dose

Interventions

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RO4995819

single oral dose

Intervention Type DRUG

activated charcoal

orally 3 times daily, Days 1-7

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects, 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
* Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.

Exclusion Criteria

* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
* Any confirmed allergic reaction against any drug or multiple allergies
* Dietary restrictions that would prohibit the consumption of standardized meals
* Positive cotinine test and/or any use of nicotine containing products
* Clinically relevant history of constipation or bowel disorder
* Known intolerability to activated charcoal
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2011-000916-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25485

Identifier Type: -

Identifier Source: org_study_id