A single-center, open-label, two sequence, crossover study to investigate the interaction between Colistin Methansulfonate Sodium (CMS) and RO7033877 in healthy subjects.

Completed

• Conditions: pneumonia; serious infections; 10004018

• Registration Number: NL-OMON41756
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

healthy male or female
18 - 55 years of age, inclusive
BMI 18.0 - 30.0 kilograms/meter2
Weight 60 kg or more, but less than 100 kg
no smokers

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate the potential pharmacokinetic (PK) drug-drug interaction between<br /><br>RO7033877 and colistin methanesulfonate sodium (CMS) in healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of RO7033877 administered alone or in<br /><br>combination with CMS in healthy subjects.</p><br>