NCT07818330尚未招募1 期
A Repeat Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Incidence of TEAEs
研究概览
简要总结
This Phase 1, 16-day Repeat dose study will evaluate the safety of a Dexmedetomidine Transdermal System (DMTS) skin system in healthy adults Subjects. Participants will receive the patch for four consecutive 4-day treatment periods. Researchers will monitor safety, drug levels in the blood, sedation effects, skin irritation, and how well the patch stays attached to the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be non-smokers, as defined by cessation of smoking and consumption of no more than 2 tobacco/nicotine-containing products within 6 months prior to screening.
- •Have a body weight > 50 kg, and body mass index (BMI) of 18.0 to 38.0 kg/m2
- •Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair, skin allergies, or sensitivities that may compromise the subject's ability to wear the investigational product at the application site for the specified duration of treatment
- •Female subjects are eligible only if all the following apply:
- •Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
- •Surgically sterile (via hysterectomy or oophorectomy); or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study
- •Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 3 months following the study.
排除标准
- •History of allergy or hypersensitivity to dexmedetomidine or dexmedetomidine hydrochloride.
- •Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS application site, according to examination by the investigator at screening or admission to the clinic.
- •History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •History of seizures.
- •Use of any prescription or non-prescription drugs (except acceptable forms of birth control, paracetamol up to 2 g per day for no more than 3 consecutive days, and ibuprofen up to 1.2 g per day for no more than 3 consecutive days for headache or dysmenorrhea, etc., per investigator discretion) within 14 days prior to study drug administration and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere
- •Significant history of postural hypotension, or history of severe dizziness or fainting upon standing in the opinion of the investigator.
- •Donation of blood or loss of blood (> 100 mL) within 30 days prior to study drug administration.
- •Had symptoms of an upper respiratory tract infection within 14 days prior to dosing of the study drug
研究组 & 干预措施
Dexmedetomidine Transdermal System (DMTS)
Experimental
干预措施: Dexmedetomidine Transdermal System (DMTS) (Drug)
结局指标
主要结局
Incidence of TEAEs
时间窗: From Day 1 to Day 15 (EOS visit)
Incidence of SAEs
时间窗: From Day 1 to Day 15 (EOS visit)
次要结局
- Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)(Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit))
- Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)(Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit))
- Sedation effect of dexmedetomidine transdermal system (DMTS)(From Day 1 to Day 13)
- Adhesion of the dexmedetomidine transdermal system (DMTS)(From Day 1 to Day 13)
- Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)(Days 1,2,3,4,5,9,10,11,12,13,14 and Day 15 (EOS visit))
研究者
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