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CMS

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

CMS · 1 trial · 1 indication

Phase 1 1
NCT02156323A 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)Healthy Volunteer
COMPLETED28 Analytics
PHASE1COMPLETED
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)
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Study Endpoints

Primary Endpoints

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 Endpoints

Incidence of adverse events (AEs)
Up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
CMSDRUGMultiple doses of CMS over 2.5 days
RO7033877DRUGMultiple doses of RO7033877 over 2.5 days
RO7033877 + CMSDRUGMultiple doses of RO7033877 and CMS over 2.5 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Netherlands
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Frequently asked questions about CMS

What is CMS?

CMS, or colistin methanesulfonate sodium, is an investigational small molecule being studied in a Phase 1 clinical trial in healthy volunteers. The trial, NCT02156323, was completed in the Netherlands and enrolled 28 participants. CMS is being developed by Roche Holding AG (RHHBY).

What is CMS used for?

CMS is being studied for use in healthy volunteers as part of a drug-drug interaction trial. The Phase 1 study investigated the interaction between multiple doses of RO7033877 and multiple doses of CMS. The trial has been completed, and CMS remains in clinical development.

Who makes CMS?

CMS is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored the Phase 1 clinical trial NCT02156323, which investigated CMS in healthy volunteers. The study has been completed.

What phase is CMS in?

CMS is in Phase 1 clinical development. The completed trial, NCT02156323, was a Phase 1 study in healthy volunteers that enrolled 28 participants. CMS is investigational and not yet approved for any use.

What clinical trials is CMS in?

CMS has one clinical trial, NCT02156323, a Phase 1 study in healthy volunteers. The trial, completed in the Netherlands, investigated the drug-drug interaction between multiple doses of RO7033877 and CMS. It enrolled 28 participants and was a controlled, randomized study.

Is CMS the same as colistin methanesulfonate sodium?

Yes, CMS is the abbreviation for colistin methanesulfonate sodium. The Phase 1 trial NCT02156323 studied the interaction between RO7033877 and colistin methanesulfonate sodium (CMS) in healthy volunteers. The trial has been completed.