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)

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: CMS; Drug: RO7033877; Drug: RO7033877 + CMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156323

NP29333

2014-000108-86 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

28 participants in 2 patient groups

Treatment Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: CMS

Drug: RO7033877

Drug: RO7033877 + CMS

Treatment Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: CMS

Drug: RO7033877

Drug: RO7033877 + CMS