An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne
详细描述
This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 18 and 35 years (inclusive) of age.
- •Clear skin or facial acne of any severity, currently untreated
- •Otherwise healthy subjects
- •Subjects who provide written informed consent to participate in the study.
- •Women of childbearing potential who are willing to use 2 reliable methods of contraception or practice abstinence during the study period or be surgically sterilized and agree to undergo repeated pregnancy tests.
- •Body Mass Index (BMI) 19.0 to <30.0 kg/m2 and weight ranging between 60-90 kg (males) and 50-85 (females).
- •Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 6 months prior to screening visit
- •Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.
- •Shaven facial hair (males)
- •Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.
- •No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
- •No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse determined within 21 days of the start of the study (screening visit).
- •Willingness to minimize exposure to sun for 20 days after first dosing
- •Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study
排除标准
- •Documented history or ongoing symptoms of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- •Known or suspected pregnancy or lactation or planned pregnancy during the study duration (females)
- •Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
- •Use of systemic corticosteroids within the past 4 weeks.
- •Use of systemic retinoids (e.g. isotretinoin) within the past 6 months.
- •Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
- •History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject's participation in the study.
- •Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- •Dermatological conditions which might have an effect upon dermal application, e.g.: Psoriasis, mycosis fungoides, widespread acne, facial or back dermatophytosis, severe hyperhydrosis, chronic or recurrent skin infections, ichtyosis
- •Excessive hair in the intended application areas
- •Current or recent (within 1year) drug or alcohol abuse.
- •Known contraindication, hypersensitivity and/or allergy to the study drug or its excipients.
- •Subjects with significant allergic response to other drugs
- •Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.
- •Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
- •Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- •Subjects unable to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
- •Subjects who are non-cooperative or unwilling to sign consent form.
研究组 & 干预措施
FMX101 Minocycline 4% foam
FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin
干预措施: FMX101, Minocycline 4% foam (Drug)
结局指标
主要结局
adverse events
时间窗: 22-25 days
AEs will be assessed starting from informed consent signature until end of study)
irritation and local reaction
时间窗: 16 days
The application area will be examined for irritation and local reaction
Change from baseline in vital signs
时间窗: 22-25 days
sitting BP, HR, RR, oral temperature
Cmax
时间窗: 16 days
will be assessed after 1 and 16 days of dosing
Tmax
时间窗: 16 days
will be assessed after 1 and 16 days of dosing
AUCT
时间窗: 16 days
will be assessed after 1 and 16 days of dosing
T½
时间窗: 16 days
will be assessed after 1 and 16 days of dosing
次要结局
未报告次要终点