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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02156323

Enrollment

Registered

2014-06-05

Start date

2014-07-31

Completion date

2015-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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).

Interventions

DRUGCMS

Multiple doses of CMS over 2.5 days

DRUGRO7033877

Multiple doses of RO7033877 over 2.5 days

DRUGRO7033877 + CMS

Multiple doses of RO7033877 and CMS over 2.5 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
Incidence of adverse events (AEs)	Up to 9 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026