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)

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: CMS; Drug: RO7033877; Drug: RO7033877 + CMS

• Registration Number: NCT02156323
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Study Start: 2014-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	CMS	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 Sequence 1	RO7033877	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 Sequence 1	RO7033877 + CMS	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 Sequence 2	CMS	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 Sequence 2	RO7033877	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 Sequence 2	RO7033877 + CMS	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to 9 weeks