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Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery

NCT06326138 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-03-22

No results posted yet for this study

Summary

The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).

Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.

All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation.

Conditions

  • Bariatric Surgery Candidate

Interventions

DRUG

Edoxaban Pharmacokinetics and Pharmacodynamics

Participants will be received single oral doses of edoxaban 60 mg.

Sponsors & Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    lead OTHER

Principal Investigators

  • Paul Poirier, MD, Phd · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-03-11
Completion
2024-03-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326138 on ClinicalTrials.gov