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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO7033877 + Bronchoscopy

• Registration Number: NCT02165293
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RO7033877	RO7033877 + Bronchoscopy	-

Primary Outcome Measures

Name	Time	Method
Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC	5 days (in-clinic period)
ELF and AM/Plasma Ratios of Cmax and AUC	5 days (in-clinic period)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to 12 days
Changes in clinical laboratory safety tests, vital signs, and ECGs	Up to 6 weeks