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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02165293 (opens ClinicalTrials.gov in a new tab)Other idNP29332
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Hoffmann-La Roche · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2014
Primary completion
Sept 2014
Completion
Sept 2014
First posted
17 Jun 2014 (estimated)
Last update posted
2 Nov 2016 (estimated)
Conditions
Healthy Volunteer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

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

    NCT02165293

    Jun 2014 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RO7033877 + BronchoscopyDrug

Arms1

  • Experimental

    RO7033877

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC

    Time frame · 5 days (in-clinic period)

  2. ELF and AM/Plasma Ratios of Cmax and AUC

    Time frame · 5 days (in-clinic period)

Secondary outcomes(2)

  1. Incidence of adverse events (AEs)

    Time frame · Up to 12 days

  2. Changes in clinical laboratory safety tests, vital signs, and ECGs

    Time frame · Up to 6 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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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