Main admission requirements

• You are between 18 and 55 years old (inclusive)
• You have a BMI between 18-30 kg/m² (inclusive)
• You have a body weight more than 50 kg (inclusive)
• Do not use nicotine-containing substances (such as cigars, nicotine patches, or e-cigarettes) from 6 months before the screening and do not smoke until the end of the study.
• You are in general good health and have no history of certain diseases.
• No participation in other studies: from 90 days before first dose; until 2 months after last follow-up. You have not previously been dosed in Part 1 of Part 2 of this study.
• If you are a woman: 
  • Either postmenopausal - No menstruation for more than 12 months
  • Or sterilized - After removal of ovaries and/or uterus, or tubal ligation.
  • Or using an effective method of contraception - During the study and for at least 34 days after the last administration of the medication.
• You are not an employee or a relative of the staff working at J&J, and/or CPU.
• You have read the complete recruitment letter with detailed conditions, explanation of the selection process, and compensation (see attached PDF documents).
• You can fully commit to participating in 1 or multiple cohorts. 

 

Compensation

If you participate in this study, you will receive compensation for the time and commitment invested. You will receive a mileage reimbursement for each visit.

• € 55 for the screening
• € 500 (including screening compensation) for the full study
• €55 for each period as reserve  

 

Study process

After formal approval by the Ethics Committee, Johnson & Johnson CPU conducts the study starting from March 2025. The study consists of 2 cohorts (groups) with a total of 9 participants. The objectives of part 3 of this study is to evaluate the effect of sweetener and/or flavoring agents on the overall acceptability (including taste) of milvexian administered as oral dispersions in healthy adult participants.

The following visits take place: 

• Initial screening visit  
  • You will read the informed consent form (ICF). To prepare, you will receive this document via e-mail prior to the screening.  
  • Next, you will have a conversation with a physician, and you can ask questions. If you wish to participate in the study, you and the physician will sign the form.  
  • The physician will review your medical history and medication use. Depending on the study, other additional examinations may take place, such as [physical examination, weight measurement, blood pressure, temperature, heart monitoring, blood and urine tests, pregnancy test, alcohol and/or drug test, or other tests.  
• Possible follow-up visits
  • Additional examinations may be scheduled throughout the study, such as additional blood tests or a visit for specialized examination. These tests and/or examinations are always done by appointment. Retesting (verification of abnormal screening results) will be conducted within +/- 7 days after screening, by appointment.  
• 3 Ambulatory visits
  • These visits take place by appointment from the morning until the afternoon.
• 1 Follow-up visit (the last visit)  
  • You will undergo a final examination to check your health status one last time. This marks the end of your participation in the study. 

 

How to register?  

Be sure to review the complete recruitment letter with detailed conditions, explanation of selection process and fees (see pdf's on this page). Check if you can free yourself in your schedule to join 1 or more groups. Preferably register online, press the 'Register for this study' button on this webpage.

Your response to this recruitment letter only indicates your interest in obtaining information and does not guarantee participation in the study.