EUCTR2014-000134-30-DE进行中（未招募）不适用
An open-label, randomised, single and repeat dose parallel group Phase I study to evaluate the pharmacokinetics of ST10 at three dosage levels in subjects with iron deficiency (with or without anaemia). - ST10-021 pharmacokinetic study in ID
Iron Therapeutics (Switzerland) AG0 个研究点目标入组 0 人开始时间: 2014年2月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject must be competent to understand the information given in the Independent Ethics Committee (IEC) approved information sheet/informed consent form and must sign and date the informed consent prior to any study mandated procedure.
- •Subject must be willing and able to comply with study requirements.
- •Subject must be at least 18 years of age, male or female.
- •Subject must have iron deficiency defined by ferritin <30 µg/L, or ferritin <50 µg/L with transferrin saturation (TSAT) < 20%, as measured by the central laboratory at the pre-study screening visit (subjects with or without anaemia may be enrolled providing Hb is ?8.5 g/dL as measured at the Screening Visit).
- •Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must be using a reliable method of contraception throughout the study. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomised partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Has untreated or untreatable severe malabsorption syndrome eg. untreated coeliac disease.
- •Has had major upper GI surgery; e.g. gastrectomy; gastric bypass or duodenal or jejunal resection; or a swallowing disorder.
- •Has received within 28 days prior to screening intramuscular or intravenous (IV) injection or administration of depot iron preparation.
- •Has received prescription or non-prescription oral iron supplementation within 7 days prior to screening.
- •Has received blood transfusion within 12 weeks prior to screening.
- •Has received erythropoiesis stimulating agents within 28 days prior to screening .
- •Serum creatinine >1.5 times the upper limit of normal as measured at the screening visit.
- •Has a known hypersensitivity or allergy to ST10 or components of the study medication.
- •Has a known contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassaemia, or lead intoxication induced anaemia.
- •Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST) >2.0 times upper normal limit as measured at the screening visit.
- •Has any other clinically significant abnormalities in pre-study screening laboratory tests, other than those related to a diagnosis of iron deficiency.
- •Active chronic or acute inflammatory disease including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant.
- •Active chronic or acute or infectious diseases requiring antibiotic treatment.
- •Women who are pregnant or breast feeding.
- •Concomitant medical conditions with extensive active bleeding, other than menstrual cycles.
- •Scheduled or expected hospitalisation and/or surgery during the course of the study.
- •Scheduled blood donations or transfusions during the study period.
- •Participation in any other interventional clinical study within 12 weeks prior to screening and through to study end; except participation and completion in the ST10-01-301 or 302 studies. Last dose of ST10 in these studies must have been at least 7 days before screening.
- •History of clinically significant coronary heart disease e.g. unstable angina, heart failure.
- •Clinically significant neurologic or psychiatric disease resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer’s disease, schizophrenia or other psychosis, alcohol or drug abuse).
- •Has any other medical condition that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or objectives of the study or severely limit the lifespan of the subject.
- •Is receiving treatment for any active malignancy.
- •Is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
研究者
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