This study is seeking healthy breastfeeding female participants.
Women of non-childbearing potential:
You may participate in this study provided that:
• You are between 18 and 55 and
• 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 these categories (described above), you will be considered as capable of having children.
Women of childbearing potential:
At each visit to the PCRU, we will check that you are using the appropriate contraception. You must fulfil one of the following conditions:
▪ You have had a bilateral tubal occlusion
▪ You have a non-hormonal IUD
▪ You have a hormonal IUS
▪ Your partner has undergone a vasectomy at least six months ago
▪ You use implantable hormonal contraception
▪ You use non-implantable hormonal contraception
▪ You are abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
These contraception methods must be used until minimum 28 days after last administration of study medicine or until the end of the study. In addition, hormonal contraceptive methods will have to be started at least 28 days before the start of the study and non-hormonal contraceptive methods will have to be started at least 14 days before the start of the study.
If you use non-implantable hormonal contraception, you must add one of the below barrier methods in order to be eligible for study participation:
▪ Male or female condom;
▪ Cervical cap, diaphragm, or sponge;
▪ A combination of male condom with either cervical cap, diaphragm, or sponge (double-barrier methods).
In addition to the criteria listed, participants must meet the following requirements:
- Weight of 50 kg minimum
- Body Mass Index of min 17.5
- Non-smoker, ex-smoker, smoker (max 5 cig/day)
- Able to meet all study visit requirements. There are other requirements for participation in this study. The study staff will explain these to you during the screening process.
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can fully determine if you qualify to enroll in the study.
The study is planned to last for approximately 9 weeks.
Several examinations or procedures will be required in connection with the study:
1. A screening examination, during which you will sign a COVID ICD and the study ICD;
2. COVID-19 assessments during residence in the PCRU
3. One treatment period organized of 5 days and 4 nights in the PCRU (from Day -1 to Day 4).
4. The follow-up phone call will take place 28 to 35 days after the last administration of the study medicine.
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.
a follow-up call at the end of the study
€ 1.670 upon completion of the study, €120 Covid and transportation fees
Interested in participating?