Main admission requirements

• You are between 18 and 60 years of age (inclusive)
• You have a BMI between 18-30 kg/m² (inclusive)
• You weight at least 50.0 kg
• No use of any tobacco products within 6 months prior to screening.Do not use nicotine-containing substances (such as cigars, nicotine patches, cigarettes, e-cigarettes, vapes, chewing tobacco or gum) during and until after completion of the study. Avoid smokey environments, BBQs, and charcoal fires.  
• You feel generally healthy and have no history of certain diseases
• You have not participated in other studies from 30 days before screening to 1 months after study completion OR for a period of time that is equal to or longer than 5 times the half-life of the previously taken investigational medication (note: the longest period applies).
• As a woman, you are:
  • Either postmenopausal - If you have not had a period for more than 12 months. Additional blood tests can provide further clarification about your menopausal status.
  • Or sterilized - After the removal of ovaries and/or uterus, the fallopian tubes are clamped or blocked. Please bring proof of the procedure during the screening.
  • Or using an effective method of contraception - During the study and for at least 90 days after the last administration of the medication.
• No employee or family member of Johnson & Johnson staff is allowed to participate.
• 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 fully in this study, you will receive compensation for the time and commitment invested. You will receive a mileage allowance for each visit.

• € 55 for the screening
• € 4310 (including screening compensation) for the full study, including reimbursement for study-related expenses, including any contraception costs.
• € 293 (including screening compensation) for the reserve  
• € 150 (including screening compensation) for the standby 

 

Study process

The study consists of 2 parts: Part 1 consists of 16 participants. Part 2 consists of 16 participants. You can only participate in one part of the study. The study is conducted after formal approval by the Ethics Committee and includes:

• 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.
• 4 Stays
  • The stays will last 4 days and 3 nights. 
  • Leaving unit and receiving visitors during the stay is not allowed
• 1 follow-up (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.