Who may participate

This study is seeking healthy male and female participants. Participants must be healthy, meaning they will not have the condition for which this treatment is being developed and are in overall good health. In addition to the criteria listed, participants must meet the following requirements:    

  • Willing and able to travel to our study facility in Brussels, Belgium 

  • Able to comply with study appointments and procedures 

     

  • For women: 

              Women of non-childbearing potential:This means that: 

  • You are post-menopausal (meaning that your last period was at least one year ago, or:
      
  • You have been surgically sterilised (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy), or;

  • you have an ovarian failure.

    If you do not fall into one of the abovementioned categories, you will be considered as capable of having children. In this case, you will not be allowed to participate in this study.

     

  • For men: 

              If you have a partner and you are not abstinent, you may take part in this study on condition that:

  • you use condoms during your participation in the study and for at least 90 days after the last administration of the study drug if your partner is a woman of childbearing potential;
    In addition to that, if your partner is a woman and she is of childbearing potential, she will have to use one of the following contraception methods:
              IUD or IUS
              hormonal contraception
     
  •  Your female partner will not need to use contraception methods as set forth above, if you have had a vasectomy more than six months ago, or if your partner is a woman that is post-menopausal or surgically sterilised.
     

  •  if you are abstinent from heterosexual intercourse with a female of childbearing potential as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, you do not have to use additional contraception.

     

  • Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >45 kg.  

 

There are other requirements for participation in this study. Please read attentively the Informed Consent Document (ICD), more explanation will be provided by the study staff during the screening process.  

Condition

Healthy

Age

From 18 years

Sex

Male and Female

Long-term follow-up

A follow-up call at the end of the study

How long is the study?

Approximately 3 months

Compensation

€ 3432.00

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

If this study may be a fit for you, you’ll be invited to a screening visit at our facility in Brussels, Belgium.  

If you choose to participate, you will be in the study for up to approximately 11 weeks, including the screening and follow-up periods. You will be screened within 28 days prior to the first dose of study intervention.
Participants will be admitted to the clinical research unit (PCRU) on Day -1 and will be required to remain in the PCRU for a minimum of 9 days until completion of Day 8 assessment in each period (2 Periods).
Throughout the study, staff will closely monitor your health status and collect data, such as the levels of the study drug in your blood and urine.
 

You will not personally derive any benefit from your participation in this study, but the results obtained could be very important for the development of medicines and treatments which will benefit other people.

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