Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326138
Status:
WITHDRAWN
Last Update Posted:
2024-03-22
First Post:
2024-03-11
Brief Title:
Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery
Sponsor:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Organization:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Study Overview
Official Title:
Pharmacokinetics and Pharmacodynamics of Edoxaban in Subjects With Severe Obesity Before and After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No support form the sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPOSE
Brief 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 n12 restrictive bariatric surgery Group 1 or Roux-en-Y gastric bypass n12 mixed bariatric surgery Group 1 or had underwent Roux-en-Y gastric bypass 12 3 months ago n12 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
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 andor assessments will be performed atduring Screening Informed consent Inclusionexclusion 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 800 AM Pharmacokinetics PK and Pharmacodynamics PD blood draws predose 05 1 15 2 25 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
Informed consent will be obtained from the subject prior to performing any of the screening assessments
The following activities andor assessments will be performed atduring Screening Informed consent Inclusionexclusion 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 800 AM Pharmacokinetics PK and Pharmacodynamics PD blood draws predose 05 1 15 2 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None