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A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers

NCT ID: NCT02165293

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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This single-center, open-label study will investigate RO7033877 concentrations in plasma and in various lung compartments, including epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration. Bronchoscopy will be performed after the start of the last infusion on Day 3 at different timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine RO7033877 concentrations. The anticipated time on study treatment is 3 days.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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RO7033877

Group Type EXPERIMENTAL

RO7033877 + Bronchoscopy

Intervention Type DRUG

Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.

Interventions

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RO7033877 + Bronchoscopy

Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female participant is eligible to participate if she is of non-childbearing potential defined as postmenopausal or surgically sterile
* Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Nonsmokers
* Healthy male volunteers with female partners of childbearing potential must use adequate contraception methods

Exclusion Criteria

* Evidence of active chronic disease
* Regular consumption of drugs of abuse
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)
* History of clinically significant hypersensitivity or allergic drug reactions
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
* Abnormal blood pressure or vital signs
* Contraindications to bronchoalveolar lavage (BAL)
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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Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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NP29332

Identifier Type: -

Identifier Source: org_study_id