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)

Hoffmann-La Roche28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Volunteer

Interventions

CMSDRUG

Multiple doses of CMS over 2.5 days

RO7033877DRUG

Multiple doses of RO7033877 over 2.5 days

RO7033877 + CMSDRUG

Multiple doses of RO7033877 and CMS over 2.5 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

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

Incidence of adverse events (AEs)

Time frame: Up to 9 weeks

Data from ClinicalTrials.gov

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