E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy blood donors and anemic patients with inflammatory bowel disease |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy blood donors and anemic patients with inflammatory bowel disease |
|
E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002295 |
E.1.2 | Term | Anemia iron deficiency |
E.1.2 | System Organ Class | 100000004851 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the dose dependency of Feramyl 200mg vs.Feramyl1000 mg administered over 1 hour intravenously with respect to Cmax, Tmax, T1/2and AUC.
To evaluate the safety of 1a1-hour infusion time by monitoring of vital signs and, clinical chemical safety parameters and adverse events.
|
|
E.2.2 | Secondary objectives of the trial |
To evaluate the Cmax, Tmax, AUC, half life, elimination constants, volumes of distribution and AUCurine excretion compared to literature data for competitors.
To evaluate standard clinical chemical safety parameters and compare the results after 200 mg to 1000 mg and compare literature data for competitors.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy volunteers:
1. Blood donor, who have donated 400 ml blood within the last 2 weeks.
2. The subject (male or female) is aged 18–45 years (inclusive).
3. The subject's body mass index is between 20 and 28 kg/m2 (inclusive).
4. The subject's systolic blood pressure is <135 mmHg AND his/her diastolic blood pressure is <95 mmHg.
5. The subject has given negative results in serological tests for human immunodeficiency virus, hepatitis C virus and hepatitis B virus surface antigen.
6. The subject has given his/her written informed consent to participate in the study by signing the Informed Consent form.
Inflammatory bowel disease patients:
1. Age between 18 and 70, both included.
2. The subject's body mass index is between 20 and 28 kg/m2 (inclusive).
3. Inflammatory bowel disease for at least 3 month.
4. Anemic defined as Hgbg/l less than 12 (women), 13 (men), ferritin, ferritin < 800 ug/L andL and TSAT < 30 %.
5. No other disease expected to reduce life expectancy.
6. The subject has given his/her written informed consent to participate in the study by signing the Informed Consent form.
|
|
E.4 | Principal exclusion criteria |
1. Known allergy to Feramyl or HES.
2. The subject regularly takes multivitamin dietary supplement and/or iron supplement. (N.B. These will be prohibited during the study.)
3. The subject (if female) is pregnant or lactating.
4. The subject's laboratory values show any abnormality that the investigator considers to warrant exclusion of the subject from participation in the study.
5. The subject has any history (or current presence) of addiction to alcohol or drugs.
6. The subject has taken part in any other clinical trial within the previous three months
7 Severe IBD, surgery within the last 8 weeks, non-iron deficient anemia, iron overload or hemosiderosis, liver cirrhosis or hepatitis, acute or chronic infections, rheumatic disease, pregnancy or breastfeeding, planned elective surgery during the study period.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |