NCT06326138

Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery

Pharmacokinetics and Pharmacodynamics of Edoxaban in Subjects With Severe Obesity Before and After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Screening visit (Group 1 and 2: visit 1) // Group 1: Screening will take place within 3 to 4-months window before bariatric surgery. Group 2: Screening will take place within 1-months window approximately 12± 3 months after bariatric surgery. Informed consent will be obtained from the subject prior to performing any of the screening assessments. The following activities and/or assessments will be performed at/during Screening: Informed consent, Inclusion/exclusion criteria, Medical history, Concomitant medications, Physical examination, including height, weight, and body mass index (BMI), Blood and urine samples, 12-lead ECG, Vital signs. Pharmacokinetic (PK) and pharmacodynamics (PD) visit Group 1: PK and PD visit will take place after the screening visit and within 3-months window before bariatric surgery as well as 48 hours after bariatric surgery. Group 2: PK and PD visit will take place after the screening visit and within 1-months window after bariatric surgery (12± 3 months). On PK and PD visit, the following procedures will be performed: Vital signs, ECG, Concomitant medications, Edoxaban dosing (before 8:00 AM), Pharmacokinetics (PK) and Pharmacodynamics (PD) blood draws (predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours), Post dose fasting and water restrictions, as appropriate, Adverse event (AE) monitoring. Follow-up 1 - Group 1 and Group 2: Follow-up 1 will take place onsite 24 hours after PK and PD visits. On follow-up 1, the following procedures will be performed: PK and PD blood draws, Concomitant medications, AE monitoring. Follow-up 2 - Group 1 and Group 2: Follow-up 2 will be a phone contact and will take place 7 days after PK and PD visits. On follow-up 2, the following procedures will be performed: Concomitant medications, AE monitoring.

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Edoxaban Pharmacokinetics and Pharmacodynamics	Participants will be received single oral doses of edoxaban 60 mg.

Timeline

• Start date: 2024-03-11
• Primary completion: 2024-03-11
• Completion: 2024-03-11
• First posted: 2024-03-22
• Last updated: 2024-03-22