Nonvalvular Atrial FibrillationNCT05715658
Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects
A study testing Dabigatran etexilate capsule in people with Nonvalvular Atrial Fibrillation and Health, Subjective, run by Dongyang Liu at 1 site in China.
Trial summary
This study intends to collect blood samples of adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation after taking dabigatran etexilate for pharmacokinetics and other studies, aiming to reveal the effect of dabigatran etexilate in Chinese elderly population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nonvalvular Atrial Fibrillation, Health, Subjective
- What is being tested?
- Dabigatran etexilate capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2022to 30 Jul 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With full capacity for civil conduct, the age of adult healthy subjects is ≥18 years old and ≤30 years old; elderly healthy subjects ≥ 75 years old; elderly patients with atrial fibrillation are ≥75 years old.
- Male weight ≥ 50 kg, female weight ≥ 45 kg; body mass index (BMI) within the range of 19.0~27.0 (including upper and lower limits), body mass index (BMI) = weight (kg) / height 2 (m2).
- Creatinine clearance rate (CRCL): calculated by Cock Croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min; elderly healthy subjects should have CRCL≥60mL/min; elderly patients with atrial fibrillation should have CRCL≥30mL/min.
- Elderly patients with atrial fibrillation should have meet the diagnostic criteria for non-valvular atrial fibrillation.
- Elderly patients with atrial fibrillation are taking Dabigatran etexilate for routine treatment.
Who cannot join
- History of fainting of needles and blood.
- Diseases affecting intestinal P-glycoprotein: severe diarrhea (excretion more than 3 times a day with watery stool characteristics), Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulitis, difficult Identify Clostridium infection (recurrent) or Helicobacter pylori infection.
- Diseases affecting the activity of CYP3A in the liver: acute kidney injury, liver cirrhosis, liver abscess, liver cancer, intrahepatic bile duct stones, etc.
- Diseases affecting changes in intestinal flora: non-alcoholic fatty liver disease, diabetes, chronic constipation.
- History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases.
- Diseases or conditions with significant risk of major bleeding, such as current or recent peptic ulcer, malignant neoplasms with high bleeding risk, recent brain or spinal cord injury, recent brain, spinal cord, or eye surgery, recent intracranial hemorrhage, known or suspected Esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracranial vascular abnormalities.
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- Clinically significant active bleeding.
- Are using anticoagulant drugs such as unfractionated heparin (UFH), low molecular weight heparin (LMWH) and heparin derivatives (fondaparinux sodium), vitamin K antagonists, rivaroxaban or other direct thrombin Inhibitors (recombinant hirudin, bivalirudin); thrombolytic drugs; or current use of antiplatelet aggregation drugs such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, dextran, sulfinpyrazone, aspirin, etc.
- Use of drugs that may affect the intestinal flora within 1 week before the trial: Continuous use of antibiotics, Bifidobacterium triple viable bacteria powder, lactobacillus tablets, compound Lactobacillus acidophilus tablets, Bacillus subtilis dual viable bacteria enteric-coated capsules, containing bismuth subsalicylate, etc.
- Use of drugs that may affect the activity of intestinal P-glycoprotein/CYP3A within 1 week before the trial: ① Potent P-glycoprotein/CYP3A inhibitors: amiodarone, verapamil, diltiazem, quinidine, dronedarone, tacrolimus, cyclosporine, protease inhibitors indinavir, nelfinavir, saquinavir, lopinavir), macrolide antibiotics (erythromycin, clarithromycin, telithromycin), chloramphenicol, azole Antifungal drugs (ketoconazole, itraconazole, Posaconazole, voriconazole, fluconazole, miconazole), nefazodone, cobicistat, cimetidine, ciprofloxacin, Imatinib, St. John's Wort, Ranolazine; ② Potent P-glycoprotein/CYP3A inducers: rifampicin, carbamazepine, phenytoin, phenobarbital, dexamethasone, antiandrogens (enzalutamide, apalutamide).
- Those who have a history of smoking and drinking in the past, and who do not agree with the prohibition of smoking and drinking during the trial period: smokers (the average daily cigarettes smoked more than 5 cigarettes within one month before the test); alcoholism (the average daily drinking within one month before the test) ≥100mL high-quality liquor (ethanol content ≥40%)).
- History of gastrointestinal surgery such as gallbladder or appendectomy, bariatric surgery, etc. within the past 6 months.
- Positive virological test (human immunodeficiency virus antibody (HIV-Ab), syphilis serological test, hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)) within 3 months before screening.
- Those who have participated in clinical trials of any drug or medical device within 1 month before screening (in the case of drug clinical trials, those who participated in the previous clinical trial before screening have more than 5 half-lives).
- Subjects who are considered by the investigator to have any factors that are not suitable for participating in this trial.
- Adult healthy subjects, with the following additional exclusion criteria:
- Pregnant and lactating women.
- Suffering from atrial fibrillation, hypertension, heart failure, coronary heart disease, heart valve disease and other diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Dongyang Liu, liudongyang@vip.sina.com
About this study
Official title: A Study Evaluating the Pharmacokinetics of Dabigatran Etexilate in Adult Healthy Subjects, Elderly Healthy Subjects, and Elderly Patients With Atrial Fibrillation
This study intends to collect blood samples of adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation after taking dabigatran etexilate for pharmacokinetics and other studies, aiming to reveal the effect of dabigatran etexilate in Chinese elderly population. Pharmacokinetic profile and biomarker concentration levels; fecal samples were collected for gut microbiota studies to further explore potential mechanisms. The results of the study may provide reference for the precision medicine of dabigatran etexilate and other drugs in the elderly population or the development of new clinical drugs.
Read the detailed description
This study is a single-center, open-label clinical study, with adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation as the research subjects. Adult healthy subjects and elderly healthy subjects only take one 110 mg dabigatran etexilate capsule (low-dose specification in the instruction manual) orally. Elderly patients with atrial fibrillation take dabigatran etexilate according to routine medical treatment. Blood samples at 0 h(before dosing), 2 h, 6 h, 10 h and 24 h after dosing, and additional stool samples were collected.
- Being tested
- Dabigatran etexilate capsule
- Keywords
- dabigatran pharmacokinetics, P-glycoprotein, older adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilate capsuleDrug
Adult healthy subjects and elderly healthy subjects only take one 110 mg dabigatran etexilate capsule (low-dose specification in the instruction manual) orally. Elderly patients with atrial fibrillation take dabigatran etexilate according to routine medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Evaluating the pharmacokinetics of dabigatran etexilate in elderly healthy subjects | Experimental | Adult healthy subjects and elderly healthy subjects only took one 110mg dabigatran etexilate capsule orally, and elderly patients with atrial fibrillation took dabigatran etexilate according to routine medical care. Receives: Drug: Dabigatran etexilate capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration in plasma of dabigatran on the first day before administration
Plasma concentration of dabigatran will be measured by LC-MS/MS or HPLC
Measured: on the first 1 day before administration
Concentration in plasma of dabigatran on the 2, 6, 10, and 24 hours after administration
Plasma concentration of dabigatran will be measured by LC-MS/MS or HPLC
Measured: on the 2, 6, 10, and 24 hours after administration
Species of intestinal flora
Bacterial composition will be measured by 16s or Metagenome
Measured: on the first 1 day before administration
Secondary outcomes (1)
Gene polymorphsim
Gene polymorphisms of CES1, CES2, P-glycolprotein will be measured
Measured: on the first 1 day before administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nonvalvular Atrial FibrillationStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Control group: 12 healthy adults (18-30 years old); Test group A: 12 elderly healthy people (≥75 years old); Test group B: 12 elderly patients with atrial fibrillation (≥75 years old).
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongyang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongyang Liu, Peking University Third Hospital
- Investigators
- Dongyang Liu, Principal investigator, Drug Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715658
- Sponsor's protocol ID
- M2022280
- Status last verified
- Feb 2023
- First submitted
- 4 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hines LE, Murphy JE. Potentially harmful drug-drug interactions in the elderly: a review. Am J Geriatr Pharmacother. 2011 Dec;9(6):364-77. doi: 10.1016/j.amjopharm.2011.10.004. Epub 2011 Nov 11.
PubMed 22078863Zorab PA. Proceedings: Prognosis for life in childhood scoliosis. Arch Dis Child. 1973 Oct;48(10):824-5. doi: 10.1136/adc.48.10.824-c. No abstract available.
PubMed 4749689Elmeliegy M, Vourvahis M, Guo C, Wang DD. Effect of P-glycoprotein (P-gp) Inducers on Exposure of P-gp Substrates: Review of Clinical Drug-Drug Interaction Studies. Clin Pharmacokinet. 2020 Jun;59(6):699-714. doi: 10.1007/s40262-020-00867-1.
PubMed 32052379
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Pharmacokinetics of Dabigatran Etexilate in Adult Healthy Subjects, Elderly Healthy Subjects, and Elderly Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05715658
- Acronym / sponsor ID
- M2022280
- Keywords
- dabigatran pharmacokinetics, P-glycoprotein, older adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dongyang LiuUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 8 Feb 2023 (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.
This study intends to collect blood samples of adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation after taking dabigatran etexilate for pharmacokinetics and other studies, aiming to reveal the effect of dabigatran etexilate in Chinese elderly population. Pharmacokinetic profile and biomarker concentration levels; fecal samples were collected for gut microbiota studies to further explore potential mechanisms. The results of the study may provide reference for the precision medicine of dabigatran etexilate and other drugs in the elderly population or the development of new clinical drugs.
Detailed description
This study is a single-center, open-label clinical study, with adult healthy subjects, elderly healthy subjects and elderly patients with atrial fibrillation as the research subjects. Adult healthy subjects and elderly healthy subjects only take one 110 mg dabigatran etexilate capsule (low-dose specification in the instruction manual) orally. Elderly patients with atrial fibrillation take dabigatran etexilate according to routine medical treatment. Blood samples at 0 h(before dosing), 2 h, 6 h, 10 h and 24 h after dosing, and additional stool samples were collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Control group: 12 healthy adults (18-30 years old); Test group A: 12 elderly healthy people (≥75 years old); Test group B: 12 elderly patients with atrial fibrillation (≥75 years old).
| Arm | Type | Receives |
|---|---|---|
| Evaluating the pharmacokinetics of dabigatran etexilate in elderly healthy subjects | Experimental | Drug: Dabigatran etexilate capsuleAdult healthy subjects and elderly healthy subjects only took one 110mg dabigatran etexilate capsule orally, and elderly patients with atrial fibrillation took dabigatran etexilate according to routine medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With full capacity for civil conduct, the age of adult healthy subjects is ≥18 years old and ≤30 years old; elderly healthy subjects ≥ 75 years old; elderly patients with atrial fibrillation are ≥75 years old.
- Male weight ≥ 50 kg, female weight ≥ 45 kg; body mass index (BMI) within the range of 19.0~27.0 (including upper and lower limits), body mass index (BMI) = weight (kg) / height 2 (m2).
- Creatinine clearance rate (CRCL): calculated by Cock Croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min; elderly healthy subjects should have CRCL≥60mL/min; elderly patients with atrial fibrillation should have CRCL≥30mL/min.
- Elderly patients with atrial fibrillation should have meet the diagnostic criteria for non-valvular atrial fibrillation.
- Elderly patients with atrial fibrillation are taking Dabigatran etexilate for routine treatment.
Key exclusion criteria (18 listed)
- History of fainting of needles and blood.
- Diseases affecting intestinal P-glycoprotein: severe diarrhea (excretion more than 3 times a day with watery stool characteristics), Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulitis, difficult Identify Clostridium infection (recurrent) or Helicobacter pylori infection.
- Diseases affecting the activity of CYP3A in the liver: acute kidney injury, liver cirrhosis, liver abscess, liver cancer, intrahepatic bile duct stones, etc.
- Diseases affecting changes in intestinal flora: non-alcoholic fatty liver disease, diabetes, chronic constipation.
- History of major diseases or newly discovered diseases: prostate cancer, leukemia, liver cancer, breast cancer, colorectal cancer, leukemia and other tumor diseases.
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 |
|---|---|---|
| Dabigatran etexilate capsuleAdult healthy subjects and elderly healthy subjects only take one 110 mg dabigatran etexilate capsule (low-dose specification in the instruction manual) orally. Elderly patients with atrial fibrillation take dabigatran etexilate according to routine medical treatment. | Drug | Evaluating the pharmacokinetics of dabigatran etexilate in elderly healthy subjects |
Primary outcome
Concentration in plasma of dabigatran on the first day before administration
Time frame: on the first 1 day before administration
Plasma concentration of dabigatran will be measured by LC-MS/MS or HPLC
Concentration in plasma of dabigatran on the 2, 6, 10, and 24 hours after administration
Time frame: on the 2, 6, 10, and 24 hours after administration
Plasma concentration of dabigatran will be measured by LC-MS/MS or HPLC
Species of intestinal flora
Time frame: on the first 1 day before administration
Bacterial composition will be measured by 16s or Metagenome
1 secondary outcome
Gene polymorphsim
Time frame: on the first 1 day before administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 22078863Hines LE, Murphy JE. Potentially harmful drug-drug interactions in the elderly: a review. Am J Geriatr Pharmacother. 2011 Dec;9(6):364-77. doi: 10.1016/j.amjopharm.2011.10.004. Epub 2011 Nov 11.
- Results publication: PubMed 4749689Zorab PA. Proceedings: Prognosis for life in childhood scoliosis. Arch Dis Child. 1973 Oct;48(10):824-5. doi: 10.1136/adc.48.10.824-c. No abstract available.
- Results publication: PubMed 32052379Elmeliegy M, Vourvahis M, Guo C, Wang DD. Effect of P-glycoprotein (P-gp) Inducers on Exposure of P-gp Substrates: Review of Clinical Drug-Drug Interaction Studies. Clin Pharmacokinet. 2020 Jun;59(6):699-714. doi: 10.1007/s40262-020-00867-1.
- 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.
Dongyang Liu principal investigator
Drug Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dabigatran etexilate capsule in people with Nonvalvular Atrial Fibrillation and Health, Subjective, run by Dongyang Liu at 1 site in China.
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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu ((86)010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration in plasma of dabigatran on the first day before administration (time frame: on the first 1 day before administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05715658, which also lists 3 linked publications.
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 8 Feb 2023.