Skip to content

Trial · Interventional

CompletedPhase 1Registry data

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)

NCTNCT02156323 (opens ClinicalTrials.gov in a new tab)Other idNP29333Other id2014-000108-86Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
28 participants (actual)
Sponsor
Hoffmann-La Roche · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Jul 2014
Primary completion
Mar 2015
Completion
Mar 2015
First posted
5 Jun 2014 (estimated)
Last update posted
2 Nov 2016 (estimated)
Conditions
Healthy Volunteer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

    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)

    NCT02156323

    Jul 2014 to Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • CMSDrug
  • RO7033877Drug
  • RO7033877 + CMSDrug

Arms2

  • Experimental

    Treatment Sequence 1

    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.

  • Experimental

    Treatment Sequence 2

    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 outcomes1

Outcomes the sponsor listed as primary.

  1. Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)

    Time frame · up to 4 days (for each period)

Secondary outcomes(1)

  1. Incidence of adverse events (AEs)

    Time frame · Up to 9 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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)

PepBank is a research reference. Talk to a doctor before you use any peptide.