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

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165293
• Other study ID #: NP29332
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2014
• Last updated: November 1, 2016
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC		5 days (in-clinic period)	No
Primary	ELF and AM/Plasma Ratios of Cmax and AUC		5 days (in-clinic period)	No
Secondary	Incidence of adverse events (AEs)		Up to 12 days	No
Secondary	Changes in clinical laboratory safety tests, vital signs, and ECGs		Up to 6 weeks	No