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OpenTrials
Completed

NCT Number: NCT02165293

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 17, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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