ISRCTN12005942进行中（未招募）1 期
A Phase I, open-label, single-dose, fixed-sequence, two-part study to evaluate the effect of itraconazole and carbamazepine on fenebrutinib pharmacokinetics in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genentech
- 入组人数
- 32
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 weight =45 kilograms (kg), within the body mass index range of 18 to 32 kilograms per metre squared (kg/m2).
- •2. Participants in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs.
排除标准
- •1. Part 2 only: Participants that test positive for human leukocyte antigen-B (HLA-B)*1502 allele and/or HLA-A 3101 allele
- •2. Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of the study drug
- •3. Evidence of any infectious, metabolic (except well-controlled/stable hypothyroidism), allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder that would preclude subject participation
- •4. Any acute or chronic liver disease, e.g., hepatitis, cirrhosis (Child-Pugh Class A, B, or C), or Gilbert’s Syndrome
- •5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy and hernia repair will be allowed
- •6. History of pancreatitis, cholecystectomy or gallstones, or clinically significant GI ulcer or bleeding
- •7. History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 5-year disease-free follow-up
- •8. Use of any moderate or strong CYP3A inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, before Check-in (Period 1 Day -1)
- •9. Participants vaccinated with live, attenuated vaccines within 6 weeks before first dosing (Period 1 Day 1)
- •10. Dyspepsia, gastroesophageal reflux disease, ulcer, or GI symptoms for which the participant has recently taken (within 14 days before Check-in [Period 1 Day -1]) prescription or over-the-counter proton-pump inhibitors (PPIs), H2 blockers, or antacids for the control of gastric acidity
研究者
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