A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | June 2014 |
| End Date: | September 2014 |
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.
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.
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)
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