ISRCTN48011192进行中（未招募）1 期
A Phase I, open-label, fixed-sequence, crossover study to investigate the effect of itraconazole (CYP3A inhibitor) and phenytoin (CYP3A inducer) on BIIB113 and the effect of BIIB113 on midazolam (CYP3A substrate) in healthy participants
Biogen (United Kingdom)0 个研究点目标入组 70 人开始时间: 2023年6月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- 性别
- All
入选标准
- •1. Body mass index (BMI) between 18 and 30 kilograms per square meter (kg/m^2) inclusive
- •2. Weight =50 kg at Screening
- •3. Negative severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) test result within 5 days of Day -1 prior to randomisation
- •4. Infertile males as defined by Clinical Trials Facilitation and Coordination Group (CTFG) guidelines:
- •4.1. Permanently sterile by bilateral orchidectomy
- •4.2. Vasectomised males defined as follows:
- •4.2.1. Minimum of 12 weeks after successful vasectomy surgical procedure, and
- •4.2.2. Documentation of confirmation of successful vasectomy by postvasectomy semen analysis – information collected at least 12 weeks after the surgery
- •5. All females of childbearing potential must practice contraception
排除标准
- •1. Suicidal ideation, per the Investigator’s clinical judgement, with some intent to act within 6 months prior to the start of Screening, per the Investigator’s clinical judgement or based on the C-SSRS, corresponding to a response of ‘Yes’ on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behaviour within 1 year prior to the start of Screening. Participants reporting suicidal ideation with intent to act or suicidal behaviour prior to the Day 1 visit should be excluded.
- •2. History of systemic hypersensitivity reaction to BIIB113, itraconazole (Part A),
- •phenytoin (Part B), midazolam (Part C), other related drugs, or the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
- •3. Any vaccination within 10 days prior to Day -1 or intention to be vaccinated within 10 days after the last dose of study treatment.
- •4. Use of any hormonal oral contraceptives, systemically acting hormone-releasing
- •contraceptive implants (excluding intrauterine devices), and hormone-replacement medication.
- •5. Use of any prescription medication, over-the-counter oral medication (excluding acetaminophen [= 2 g/day]) or dietary and herbal supplements that are not inducers or inhibitors of drug metabolising enzymes or drug transporters within 7 days prior to Day -1, and an unwillingness or inability to refrain from this use during study participation, unless specifically permitted elsewhere within the protocol.
- •6. Use of any prescription medication, over-the-counter oral medication, or dietary and herbal supplements (e.g., St. John’s wort) that are a known inducer or inhibitor of drug metabolising enzymes (including but not limited to CYP3A) or drug transporters within 28 days of Day -1 and an unwillingness to refrain from use during study participation.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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