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Rivaroxaban sotorasib interaction study (the ROSIE-study)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505557-41-00
Enrollment
22
Registered
2023-08-01
Start date
2023-11-09
Completion date
2024-03-21
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Brief summary

The geometric mean ratios of AUC and Cmax of rivaroxaban in absence and presence of sotorasib.

Detailed description

Description of the pharmacokinetics of sotorasib in healthy volunteers, by means of standard compartmental or non-compartmental pharmacokinetic methods., Description of the safety of sotorasib and rivaroxaban, graded with the most recent version (v6) of the Common Toxicity Criteria for Adverse Events.

Interventions

Sponsors

Stichting Radboud University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The geometric mean ratios of AUC and Cmax of rivaroxaban in absence and presence of sotorasib.

Secondary

MeasureTime frame
Description of the pharmacokinetics of sotorasib in healthy volunteers, by means of standard compartmental or non-compartmental pharmacokinetic methods., Description of the safety of sotorasib and rivaroxaban, graded with the most recent version (v6) of the Common Toxicity Criteria for Adverse Events.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026