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

NCT02165293 | Completed Phase 1

• 1 other identifier: NP29332
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of adverse events (AEs)

  Up to 12 days

• Changes in clinical laboratory safety tests, vital signs, and ECGs

  Up to 6 weeks

Study Arms (1)

RO7033877

EXPERIMENTAL

Drug: RO7033877 + Bronchoscopy

Interventions

RO7033877 + Bronchoscopy 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.

RO7033877

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)