Investigating how D-mannose affects the absorption of dabigatran in healthy adults

A Prospective, Single-Center, Open-Label Study of the Effect of Oral D-mannose Tablets on the Pharmacokinetics of Dabigatran Etexilate in Healthy Adults

This study is testing if taking D-mannose tablets affects how well the blood thinner dabigatran works in healthy adult men.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Peking University Third Hospital (Academic / other)
• Drugs / interventions: imatinib
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06360055 on ClinicalTrials.gov

What this trial studies

This study aims to explore the impact of oral D-mannose tablets on the pharmacokinetics of dabigatran etexilate in healthy adult males. Participants will receive a single dose of dabigatran on two occasions, while taking D-mannose tablets daily for two weeks. Blood samples will be collected at various intervals to measure dabigatran levels and D-mannose concentrations. The study is designed as a prospective, single-center, open-label trial.

Who should consider this trial

Good fit: Ideal candidates are healthy male adults aged 18 to 45 with a BMI between 19.0 and 27.0 and a creatinine clearance rate of at least 90 mL/min.

Not a fit: Patients with conditions affecting intestinal P-glycoprotein or those with a history of significant bleeding risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of drug interactions and improve the safety and efficacy of dabigatran therapy.

How similar studies have performed: While the specific combination of D-mannose and dabigatran has not been extensively studied, previous research on drug interactions involving P-glycoprotein substrates has shown promising results.

Eligibility criteria

Inclusion Criteria:

1. With full capacity for civil conduct, the age of healthy male subjects is ≥18 years old and ≤45 years old
2. Male weight ≥50 kg; body mass index (BMI) within the range of 19.0\~27.0 (including upper and lower limits)
3. Creatinine clearance rate (CRCL: calculated by Cock croft-Gault equation, adult healthy subjects should have CRCL≥90mL/min

Exclusion Criteria:

1. History of fainting of needles and blood.
2. 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.
3. Diabetes mellitus; Impaired fasting glucose (IFG); Impaired glucose tolerance (IGT); Oral hypoglycemic agents (including the use of hypoglycemic agents for weight loss purposes).
4. 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.
5. Clinically significant active bleeding.
6. Taking anticoagulants 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.
7. Use of drugs that may affect the activity of intestinal p-glycoprotein within 1 week before the trial: (1) potent p-glycoprotein 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, cyclosporin, fluvoxamine, imatinib, St. John's Wort, ranolazine; (2) Potent P-glycoprotein inducers: rifampicin, carbamazepine, phenytoin, phenobarbital, antiandrogens(enzalutamide, apalutamide), phenobarbital, dexamethasone.
8. 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/200mL wine / 600mL beer).
9. History of gastrointestinal surgery such as gallbladder or appendectomy, bariatric surgery, etc. within the past 5 years.
10. 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 6 months before screening.
11. Those who have participated in clinical trials of any dug or medial device within 6 months 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).
12. Subjects who are considered by the investigator to have any factors that are not suitable for participating in this trial.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Dongyang Liu

Conditions Health; D-mannose; Dabigatran Etexilate; P-glycoprotein; pharmacokinetics