ISRCTN23183841进行中（未招募）1 期
A phase I, open-label, randomized, 2-part study to evaluate the bioequivalence of single oral doses of 2 different formulations of fenebrutinib and the effect of food and rabeprazole on the pharmacokinetics of fenebrutinib in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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. Males or females, between 18 and 60 years of age, inclusive.
- •2. Body weight =45 kilograms (kg) and within body mass index (BMI) range of 18 to 32 kilogram per meter square (kg/m²), inclusive.
- •3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs.
- •4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], complete blood count (CBC), and coagulation testing [prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT)]) and urinalysis (UA) with complete microscopic analysis are within the reference range for the test laboratory, or clinically acceptable to the investigator if outside the normal range.
- •5. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1; does include alcohol).
- •6. Negative hepatitis panel (hepatitis B surface antigen [HBsAg], hepatitis B virus core antibody, hepatitis B surface antibody [unless consistent with vaccination or immunity due to natural infection], and hepatitis C virus antibody) and negative HIV antibody screens.
- •7. For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception, and agreement to refrain from donating eggs, as defined in the protocol.
- •8. For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom with spermicide, and agreement to refrain from donating sperm, as defined in the protocol.
- •9. Any participant (male or female) who is abstinent or in a homosexual relationship at the time of signing ICF and becomes sexually active or in a heterosexual relationship during the above-defined period must agree to use a highly effective contraception as listed above.
- •10. For Part 2: able to complete a standard high-fat meal within 30 minutes.
- •11. Able to comprehend and willing to sign an informed consent form (ICF).
排除标准
- •1. 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. Females must have a negative serum pregnancy test result at Screening and Check-in (Day -1)
- •2. Evidence of any infectious, metabolic, allergic, dermatological, hepatic (including Gilbert’s syndrome), renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder that, in the investigator’s opinion, would preclude subject participation
- •3. Known or suspected active infection at Screening or baseline (excluding onychomycosis), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to or during Screening or treatment with oral antimicrobials within 2 weeks prior to or during Screening
- •4. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- •5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except for appendectomy or hernia repair which will be allowed.
- •6. Participation in any other trial in which receipt of an investigational study drug occurred within 3 months or 5 half-lives, whichever is longer, prior to Check-in (Day -1)
- •7. History of any drug or alcohol abuse within 12 months prior to Screening and/or alcohol consumption of >2 units per day for males and >1 unit per day for females. One unit of alcohol equals 285 mL of beer or lager, 25 mL liquor, or 84 mL wine
- •8. Use of any moderate or strong CYP3A inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1)
- •9. Dyspepsia, gastroesophageal reflux disease (GERD), ulcer, or GI symptoms for which the subject has recently taken (within 14 days prior to Check-in [Day -1]) prescription or over-the-counter proton pump inhibitors (PPIs), H2 blockers, or antacids for the control of gastric acidity
- •10. Use of any prescription medications/products within 14 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1), unless deemed acceptable by the investigator
- •11. Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 14 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1), unless deemed acceptable by the investigator
- •12. Participants vaccinated with live, attenuated vaccines (e.g., the intranasal live attenuated influenza vaccines, Bacillus Calmette- Guérin virus, varicella) within 6 weeks prior to first dosing (Day 1 of Period 1)
- •13. History of pancreatitis, cholecystectomy or gallstones, or clinically significant GI ulcer or bleeding
- •14. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1) and during the entire study
- •15. Use of furanocoumarin derivatives (e.g., grapefruit, Seville oranges, pomegranates, or star fruit) or poppy seed-containing foods or beverages within 7 days prior to Check-in (Day -1), unless deemed acceptable by the investigator
- •16. Use of alcohol- or caffeine-containing foods or beverages within 48 hours prior to Check-in (Day -1), unless deemed acceptable by the investigator
研究者
相似试验
已完成
不适用
A phase 1, two-part, randomized, open-label study to evaluate the relative bioavailability and food effect of test formulations of VX-152 and Ivacaftor in healthy subjects10038686Cystic FibrosisNL-OMON43101Vertex Pharmaceuticals30
进行中（未招募）
1 期
Study that tested S64315 plus different standard treatments in patients with breast cancerEUCTR2019-000998-23-ESInstitut de Recherches Internationales Servier
进行中（未招募）
不适用
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX6 + Cetuximab versus FOLFIRI + Cetuximab as first-line therapy in patients with metastatic colorectal cancerEUCTR2004-002391-42-HUCECOG (Central European Cooperative Oncology Group)150
进行中（未招募）
不适用
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with K-ras wild-type metastatic colorectal cancerEUCTR2006-006941-15-GRCECOG (Central European Cooperative Oncology Group)150
进行中（未招募）
不适用
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with metastatic colorectal cancerfirst-line therapy in patients with metastatic colorectal cancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2006-006941-15-LVCECOG (Central European Cooperative Oncology Group)150