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)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Colistin

Criteria

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)