An open label study on safety and pharmacokinetics of an intravenous administered single dose of Feramyl 200 mg in healthy blood donors compared to a single dose of Feramyl 1000 mg in IBD patients to evaluate dose dependency and kinetics after 1 hour infusion.

Active, not recruiting

• Conditions: Healthy blood donors and anemic patients with inflammatory bowel disease; MedDRA version: 14.1Level: LLTClassification code 10002295Term: Anemia iron deficiencySystem Organ Class: 100000004851; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-001123-39-DK
• Lead Sponsor: SerumWerk Bernburg AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-29
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 16

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified