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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO7033877 + Bronchoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02165293

NP29332

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

32 participants in 1 patient group

RO7033877

Experimental group

Treatment:

Drug: RO7033877 + Bronchoscopy