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NCT Number: NCT02156323

A Phase 1 Clinical Study in Healthy Volunteers to Investigate the Drug-drug Interaction Between Multiple Doses of RO7033877 and Multiple Doses of Colistin Methanesulfonate Sodium (CMS)

This single center, open-label, randomized study will investigate the drug-drug interaction potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate sodium (CMS).

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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

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult male or female (of non childbearing potential) healthy volunteers between 18 to 55 years
  • Body mass index (BMI) between 18 and 30 kg/m2
  • Non smokers
  • Use adequate contraception methods

Exclusion criteria

  • Evidence of active of chronic disease
  • Regular consumption of drugs of abuse
  • Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
  • History of significant allergic reactions
  • Abnormal blood pressure
  • Clinically significant abnormalities (e.g. cardiovascular, laboratory values)

Treatment and study plan

CMS

Drug

Multiple doses of CMS over 2.5 days

RO7033877

Drug

Multiple doses of RO7033877 over 2.5 days

RO7033877 + CMS

Drug

Multiple doses of RO7033877 and CMS over 2.5 days

Primary outcomes

  1. Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)

    Time frame: up to 4 days (for each period)

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO SEQUENCE, 3-WAY CROSSOVER STUDY TO INVESTIGATE THE INTERACTION BETWEEN MULTIPLE DOSES OF COLISTIN METHANESULFONATE SODIUM (CMS) AND MULTIPLE DOSES OF RO7033877 IN HEALTHY SUBJECTS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 5, 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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