EUCTR2013-005569-38-NL进行中（未招募）不适用
A phase I/IIa open-label First-in-Human study to assess safety and pharmacokinetics and explore biomarker effects of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in subjects with cutaneous warts - Safety, PK and biomarker effects of ICVT in subjects with cutaneous warts.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1. Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis.);
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
- •3. Fitzpatrick skin type I-II-III-IV;
- •4. At least 4 cutaneous warts on the hands, separated by at least 1 cm of skin;
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- •2. For women: a positive pregnancy test and/or nursing at screening;
- •3. A positive test for drugs of abuse at screening;
- •4. Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to enrolment;
- •5. Have received cryotherapy in the treatment area within 60 days prior to enrolment;
- •6. Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrolment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
- •7. Subjects currently using systemic digoxin or furosemide or any of the following prohibited medications (Note: exceptions will only be made if the rationale is discussed and clearly documented between the investigator and the sponsor):
- •Potential drug interactions with furosemide:
- •Aminoglycoside antibiotics
- •Ethacrynic acid
- •Salicylates
- •Tubocurarine
- •Suyccinlycholine
- •ACE inhibitors
- •Chloral hydrate
- •Methotrexate
- •Cephalosporins
- •Cyclosporine
- •Potential drug interactions with digoxin:
- •Potassium-depleting diuretics
- •Propafenone
- •Indomethacin
- •Intraconazole
- •Spironolactone
- •Beta-adrenergic blocking agents
- •Calcium channel blockers
- •8. Have any current and / or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of herpes simplex virus labialis);
- •9. Have any current uncontrolled infection;
- •10. Atopic dermatitis or any other skin diseases involving chronic inflammation or reducing the skin barrier function;
- •11. Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide.
研究者
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