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)
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
2 other identifiers
interventional
28
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedNovember 2, 2016
November 1, 2016
8 months
June 3, 2014
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)
up to 4 days (for each period)
Secondary Outcomes (1)
Incidence of adverse events (AEs)
Up to 9 weeks
Study Arms (2)
Treatment Sequence 1
EXPERIMENTALParticipants 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.
Treatment Sequence 2
EXPERIMENTALParticipants 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.
Interventions
Multiple doses of RO7033877 and CMS over 2.5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Zuidlaren, 9471 GP, Netherlands
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 5, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11