NL-OMON47992已完成不适用
A phase 1, open-label, fixed-sequence, drug-drug interaction study of APX001 to evaluate the effects of CYP3A4 inhibition and pan-CYP induction in two parallel groups of healthy male and female subjects - A DDI study of CYP3A4 inhibition and pan-CYP induction on APX001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy male or female subjects, aged 18 to 60 years inclusive at Screening.
- •- Women must be postmenopausal or surgically sterile, or
- •- Women of childbearing potential, with a fertile male sexual partner, must
- •agree to avoid pregnancy during the study and to use 2 methods of birth control
- •(using hormonal contraceptives or an intrauterine device combined with at least
- •1 of the following forms of contraception: a diaphragm or cervical cap, or a
- •condom) at least 2 weeks before the start of study drug administration (as long
- •as on one effective method for at least 3 cycles prior to dosing), or
- •abstinence, which is considered an effective method if it is defined as a
- •lifestyle preference (refraining from heterosexual intercourse) for the
- •duration of study participation, and for 3 months after the last dose of study
- •drug. At Screening and at Admission on Day -1, female subjects must be
- •nonpregnant and nonlactating.
- •- Male subjects with partner(s) of childbearing potential must agree to use
- •appropriate barrier contraception to avoid fathering a child from first
- •Admission to the clinical research unit until 3 months after receiving the last
- •dose of study drug. They must commit to abstinence from heterosexual
- •intercourse, or agree to use appropriate barrier contraception, and the use of
- •hormonal contraceptives or an intrauterine device by the female partner. Male
- •subjects must not donate sperm from first Admission to the clinical research
- •unit until 3 months after receiving the last dose of study drug.
- •2. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive.
- •3. Weight : >=50 kg.
- •4. Screening hematology, clinical chemistry, coagulation, and urinalysis
- •consistent with overall good health and the following criteria are met:
- •- Creatinine within normal limits.
- •- Estimated (Chronic Kidney Disease Epidemiology Collaboration equation)
- •creatinine clearance within normal limits.
- •5. Able to understand and comply with the requirements of the study, willing to
- •return for all clinic visits, including the confinement periods, and complete
- •all study-related procedures.
- •6. Willing and able to provide written informed consent.
排除标准
- •1. Having any uncontrolled or active major systemic disease including, but not
- •limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital,
- •neurological, immunological, psychiatric, or neoplastic disorder with
- •metastatic potential.
- •2. History or presence of malignancy within the past year. Subjects who have
- •been successfully treated with no recurrence of basal cell carcinoma of the
- •skin or carcinoma in-situ of the cervix may be enrolled.
- •3. Active acute or chronic infection, including, but not limited to: upper
- •airway infection, urinary tract infection, or skin infection within 30 days
- •preceding entry into the study.
- •4. Significant and/or acute illness within 5 days prior to the first study drug
- •administration that may impact safety assessments, in the opinion of the
- •Investigator.
- •5. Participation in an investigational drug study within 60 days prior to the
- •first study drug administration in the current study. Participation in more
- •than 3 other drug studies in the 10 months prior to the first study drug
- •administration in the current study.
- •Further criteria apply
研究者
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