NCT04138693已完成不适用
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of G-PUR® on Enteral Lead Isotope 204Pb-absorption
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 204PbB Cmax normalized for total PbB
研究概览
简要总结
This is a prospective, randomized, placebo-controlled, double blind, parallel-arm study in a two-staged approach that will assess the effect of two different doses of G-PUR® on enteral lead absorption in healthy adults using a stable lead isotopic tracer (204Pb).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects
- •Age 18-45 years
- •BMI 19-27 for males and BMI 17-25 for female
- •Blood lead (PbB) concentration < 40 μg/l
- •Serum ferritin concentration within the sex-specific normal range, i.e. ≥ 15 - 150 ng/ml for women and 30 - 400 ng/ml for men
- •Presence of scalp hair with a minimum length of 5 mm and willingness to remove 5 single hairs with hair roots at end of study visit
- •Subject is in good clinical and mental health as established by medical history and physical examination
- •Stable eating habits, within one month before the start of the study
- •Subject agrees to be compliant for study related diet schedule
- •Women of childbearing potential agree to use adequate birth control methods during the study (for all females, negative pregnancy test at screening and at Visit 3 before dosing of IMD is required. Females of childbearing potential must use adequate contraception during the entire study period. Acceptable methods of contraception include: oral contraceptives, intrauterine device, female or male condoms with spermicide, diaphragm with spermicide, contraceptive medication patch, contraceptive medication implant, contraceptive medication injection, abstinence, or surgical sterilization more than 3 months before randomization.
- •Written informed consent
排除标准
- •Pregnancy and breastfeeding
- •Lack of willingness or capacity to co-operate appropriately
- •Regular use of medications or iron supplements in the previous 2 months except intake of contraceptives
- •Planning to shave head during study
- •History of malignancies within the past two years or on current anticancer treatment
- •History of gastrointestinal pathology such as gastritis, gastric ulcers, irritable bowel disease, inflammatory bowel disease, chronic constipation
- •History of diarrhoea within the past 14 days of screening
- •History of gastrointestinal surgery with exception of appendectomy
- •History of chronic autoimmune disease requiring treatment within the past two months of screening
- •Known diabetes mellitus I or II or Hba1c >6.5%
- •Known symptomatic food allergies
- •Any clinically relevant laboratory abnormalities in screening test
- •Alcohol, cigarette or drug abuse
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- •Presence of any condition that impacts compliance with the study procedures
- •Use of any regular medication (prescription or over the counter) for prevention or treatment of any medical condition
- •Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period
- •Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
- •IMD should not be applied to patients that suffer from aluminium and/or silicon hypersensitivity or in case of renal failure that requires dialysis.
研究组 & 干预措施
Cohort 1: 2 x 2.0 g G-PUR® oral suspension
Experimental
干预措施: G-PUR® 2x 2.0 g oral suspension (Device)
Cohort 2: 1 x 2.0 g G-PUR® oral suspension
Experimental
干预措施: G-PUR® 1x 2.0 g oral suspension (Device)
Cohort 3: Placebo oral suspension
Placebo Comparator
干预措施: Placebo oral suspension (Device)
结局指标
主要结局
204PbB Cmax normalized for total PbB
时间窗: 216 hours
Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water
次要结局
- Plasma PK parameters - AUC0-t of 204PbB(216 hours)
- Incidence of (S)ADE(216 hours)
- Plasma PK parameters - tmax of 204PbB(216 hours)
- 204Pb concentrations in 24-hour urine(24 hours)
- 204Pb in single hairs(9 days)
研究者
研究点 (1)
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