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A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

NCT ID: NCT01802853

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A: RO6811135 s.c.

Group Type EXPERIMENTAL

RO6811135

Intervention Type DRUG

Single subcutaneous dose

B: RO6811135 i.v.

Group Type ACTIVE_COMPARATOR

RO6811135

Intervention Type DRUG

Single intravenous dose

Interventions

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RO6811135

Single subcutaneous dose

Intervention Type DRUG

RO6811135

Single intravenous dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male healthy volunteers, 18-45 years of age inclusive
* Healthy as determined by screening assessments
* Body mass index (BMI) between 18-30 kg/m2

Exclusion Criteria

* Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
* Any history of alcohol and/or drug of abuse addiction during the past 5 years
* Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
* Any clinically relevant abnormal test results prior to first dosing
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1
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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Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-005773-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28438

Identifier Type: -

Identifier Source: org_study_id