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)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: CMS
* Drug: RO7033877
* Drug: RO7033877 + CMS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br>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. | Drug: CMS<br>* Multiple doses of CMS over 2.5 days<br>Drug: RO7033877<br>* Multiple doses of RO7033877 over 2.5 days<br>Drug: RO7033877 + CMS<br>* Multiple doses of RO7033877 and CMS over 2.5 days<br>|
| Experimental: Treatment Sequence 2<br>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. | Drug: CMS<br>* Multiple doses of CMS over 2.5 days<br>Drug: RO7033877<br>* Multiple doses of RO7033877 over 2.5 days<br>Drug: RO7033877 + CMS<br>* Multiple doses of RO7033877 and CMS over 2.5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to 9 weeks |