Bariatric Surgery CandidatePhase 1EXPOSENCT06326138
Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery
A Phase 1 study testing Edoxaban Pharmacokinetics and Pharmacodynamics in people with Bariatric Surgery Candidate, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Edoxaban Pharmacokinetics and Pharmacodynamics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2024to 11 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects over 18 years of age.
- Females who are of non-childbearing potential must be:
- Surgically sterile (i.e., bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing).
- Naturally postmenopausal (spontaneous cessation of menses) for at least 12 consecutive months prior to screening visit, with a follicle stimulating hormone level in the postmenopausal range.
- Females of childbearing potential must have a negative urine pregnancy test at each study visit with PK and PD evaluation.
- Subjects must agree not to donate blood, plasma, platelets, or any other blood components for 4 weeks before each study visit with PK and PD evaluation.
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- Subjects must agree to food and drug restrictions during the study.
- Subjects must agree to abstain from alcohol, cola, tea, coffee, chocolate, and other caffeinated drink and food from 2 days before each study visit with PK and PD evaluation.
- Subjects must agree to abstain from food and beverages containing grapefruit, grapefruit juice, cranberry juice, lime, pomelo, marmalade and Seville oranges from 10 days before each study visit with PK and PD evaluation.
- Absence of clinically significant deviations from medical history, physical examination and 12-lead ECG, as deemed by the Investigator, prior to enrollment.
- Subject must have sinus rhythm on the 12-lead ECG at each study visit with PK and PD evaluation.
- Has given written informed consent prior to participating in the study.
- Able to understand and willing to comply with all study requirements, and willing to allow the collection of all blood specimens.
- Normal coagulation values from INR (< 1.2).
Who cannot join
- History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by screening medical history, physical examination, or 12-lead ECG.
- Subjects with QTcF interval duration > 450 msec for males and >470 for females.
- Subjects with abnormal waveform morphology on any of the ECGs at the screening that would preclude accurate measurement of the QT interval duration.
- Subjects with a resting systolic (treated) blood pressure > 159 mmHg or < 90 mmHg or a diastolic blood pressure > 95 mmHg or < 50 mmHg.
- History of malignancy.
- Subjects who have had a clinically significant illness within 4 weeks prior to the first dose.
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- Subjects who have used any drugs or substances known to be strong inhibitors or strong inducers of CYP 3A4/5 enzymes or P-gp within 28 days prior to the first dosing.
- Subjects with history of major bleeding, major trauma, or major surgical procedure of any type within 6 months of dosing.
- Subjects with history of peptic ulcer, gastrointestinal bleeding (including hematemesis, melena, rectal bleeding) or bleeding from hemorrhoids.
- Subjects with history of thrombophlebitis or pulmonary embolism.
- Subjects with history of minor bleeding episodes such as epistaxis, rectal bleeding (spots of blood on toilet paper), and gingival bleeding within 3 months before the first dose.
- Subjects who have any family history (suspected or documented) of coagulopathy.
- Females with a history of dysfunctional uterine bleeding, including history of menorrhagia (heavy menstrual bleeding), metrorrhagia, or polymenorrhea.
- Subjects with eye surgeries or trauma to the head or eye within 14 days of the first dose.
- Subjects who have used fish oil, acetylsalicylic acid, any over-the-counter medication containing acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs), or other supplements (e.g., gingko biloba, …) that could prolong bleeding within 14 days of the first dose or expect to use these during the study.
- Subjects who have used anticoagulants (i.e., warfarin, low molecular weight heparin [LMWH]), coagulants, anti-platelet (i.e., clopidogrel) 30 days prior to the first dose.
- Subjects with abnormal complete blood count at screening.
- Subjects with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
- Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study or is receiving other investigational agents.
- Subjects who, in the opinion of the Investigator, should not participate in the study.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Edoxaban in Subjects With Severe Obesity Before and After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass
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.
Read the 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
- Being tested
- Edoxaban Pharmacokinetics and Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edoxaban Pharmacokinetics and PharmacodynamicsDrug
Participants will be received single oral doses of edoxaban 60 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Roux en Y gastric bypass and Sleeve Gastrectomy | Experimental | Edoxaban pharmacodynamic and pharmacokinetic will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Receives: Drug: Edoxaban Pharmacokinetics and Pharmacodynamics |
| Group 2 - Roux en Y gastric bypass | Experimental | Edoxaban pharmacodynamic and pharmacokinetic will be evaluated at 12 ± 3 months following Roux-en-Y gastric bypass surgery. Receives: Drug: Edoxaban Pharmacokinetics and Pharmacodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics edoxaban parameter
Maximum edoxaban plasma concentration
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacokinetics edoxaban parameter
Time to reach maximum edoxaban plasma concentration
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacokinetics edoxaban parameter
Area under the edoxaban plasma concentration-time curve
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacokinetics edoxaban parameter
Edoxaban half time
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Secondary outcomes (3)
Pharmacodynamics edoxaban parameter
aPTT
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacodynamics edoxaban parameter
PT/INR
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacodynamics edoxaban parameter
anti-FXa activity
Measured: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start11 Mar 2024
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Why it stopped: No support form the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery. Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Poirier, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Paul Poirier, MD, Phd, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326138
- Sponsor's protocol ID
- 22121
- Acronym
- EXPOSE
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Edoxaban in Subjects With Severe Obesity Before and After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT06326138
- Acronym / sponsor ID
- EXPOSE / 22121
- Conditions
- Bariatric Surgery Candidate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No support form the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery. Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Roux en Y gastric bypass and Sleeve Gastrectomy | Experimental | Drug: Edoxaban Pharmacokinetics and PharmacodynamicsEdoxaban pharmacodynamic and pharmacokinetic will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). |
| Group 2 - Roux en Y gastric bypass | Experimental | Drug: Edoxaban Pharmacokinetics and PharmacodynamicsEdoxaban pharmacodynamic and pharmacokinetic will be evaluated at 12 ± 3 months following Roux-en-Y gastric bypass surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female subjects over 18 years of age.
- Females who are of non-childbearing potential must be:
- Females of childbearing potential must have a negative urine pregnancy test at each study visit with PK and PD evaluation.
- Subjects must agree not to donate blood, plasma, platelets, or any other blood components for 4 weeks before each study visit with PK and PD evaluation.
- Subjects must agree to food and drug restrictions during the study.
Key exclusion criteria (20 listed)
- History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by screening medical history, physical examination, or 12-lead ECG.
- Subjects with QTcF interval duration > 450 msec for males and >470 for females.
- Subjects with abnormal waveform morphology on any of the ECGs at the screening that would preclude accurate measurement of the QT interval duration.
- Subjects with a resting systolic (treated) blood pressure > 159 mmHg or < 90 mmHg or a diastolic blood pressure > 95 mmHg or < 50 mmHg.
- History of malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edoxaban Pharmacokinetics and PharmacodynamicsParticipants will be received single oral doses of edoxaban 60 mg. | Drug | Group 1 - Roux en Y gastric bypass and Sleeve Gastrectomy, Group 2 - Roux en Y gastric bypass |
Primary outcome
Pharmacokinetics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Maximum edoxaban plasma concentration
Pharmacokinetics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Time to reach maximum edoxaban plasma concentration
Pharmacokinetics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Area under the edoxaban plasma concentration-time curve
Pharmacokinetics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Edoxaban half time
3 secondary outcomes
Pharmacodynamics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacodynamics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Pharmacodynamics edoxaban parameter
Time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Poirier, MD, Phd principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Edoxaban Pharmacokinetics and Pharmacodynamics in people with Bariatric Surgery Candidate, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics edoxaban parameter (time frame: 0 hour (before taking edoxaban) - 0.5 hours - 1 hour - 1.5 hours - 2 hours - 2.5 hours - 3 hours - 4 hours - 6 hours - 8 hours - 12 hours - and 24 hours after taking edoxaban). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.