C5381001 C1 & C2

Who may participate

You may not take part in this study if:

• You are outside of the limits for this study of age (18-65 years) or under the limits of weight (more than 50 kg), or outside the limits for Body Mass Index (16 - 32 kg/m2).

• You smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco / nicotine-containing products.

• You have a history of undesired reaction to the sun (photosensitivity) or after taking a drug (phototoxicity);

• You have a significant iron deficiency, iron utilization or iron storage disorder (e.g. hemochromatosis, sideroblastic anaemia);

• You have a significant haemoglobin abnormalities (e.g. anaemia, thalassemia);

• You have had a recent blood donation (within 60 days prior to first dose).

• Contraception:

      For men:
      • If you have a partner and you are not abstinent, you may take part in this study on condition that:
           o you use condoms during your participation in the study and for at least 28 days after the last administration of the study drug to prevent, among other things, the possible transfer of the study drug through the semen during the study, if your partner is a woman of childbearing potential;
          o In addition to that, she will have to use one of the following contraception methods:
                 IUD or IUS
                 hormonal contraception
          o 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 sterilized.
      • 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.

       For women:
       You may participate in this study, provided that:
       • you are post-menopausal (meaning that your last period was at least one year ago, or:
              o you have been surgically sterilized (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy), or;
              o 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.

There are other requirements for participation in this study. The study staff will explain these to you during the screening process.

What to expect

The study is planned to last for approximately 30 weeks.
Several examinations or procedures will be required in connection with the study:

• A screening examination, during which you will sign the study ICD;
• 4 treatment periods, each period comprised of 5 days and 4 nights in the PCRU, with a total duration of 20 days and 16 nights in the PCRU. Each of the 4 treatment periods will be separated by an interval of at least 7 days.
• The first two participants, as assigned by the investigator in screening order, might receive the study medicine and be observed for 24 hours or more, prior to the other participants receiving the study medicine. If the dose level of study medicine is judged to be safe, the remaining participants of that cohort will receive the study medicine as well. Participants might be admitted together at the same time or in separate groups.
• The check-up visit and follow-up phone call will take place approximately 7-10 and 28-35 days respectively after the last administration of the study drug (Day 1).

View the calendar