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)
NCT ID: NCT02156323
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2014-07-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
CMS
Multiple doses of CMS over 2.5 days
RO7033877
Multiple doses of RO7033877 over 2.5 days
RO7033877 + CMS
Multiple doses of RO7033877 and CMS over 2.5 days
Treatment Sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
CMS
Multiple doses of CMS over 2.5 days
RO7033877
Multiple doses of RO7033877 over 2.5 days
RO7033877 + CMS
Multiple doses of RO7033877 and CMS over 2.5 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CMS
Multiple doses of CMS over 2.5 days
RO7033877
Multiple doses of RO7033877 over 2.5 days
RO7033877 + CMS
Multiple doses of RO7033877 and CMS over 2.5 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) between 18 and 30 kg/m2
* Non smokers
* Use adequate contraception methods
Exclusion Criteria
* 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)
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zuidlaren, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-000108-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP29333
Identifier Type: -
Identifier Source: org_study_id