ISRCTN17780768进行中（未招募）1 期
A Phase I, single center, randomized, open-label study investigating the effect of formulation, and active pharmaceutical ingredient particle size on the pharmacokinetics of fenebrutinib in healthy subjects
Genentech, Inc. c/o F. Hoffmann-La Roche Ltd0 个研究点目标入组 46 人开始时间: 2022年8月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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. Aged 18 to 60 years, inclusive, at the time of signing the Informed Consent Form (ICF)
- •2. Healthy male subjects or healthy non-pregnant, non-lactating female subjects of non-childbearing potential. Female subjects must be either postmenopausal or surgically sterile
- •3. A body mass index (BMI) between 18.0 and 32.0 kg/m², inclusive, at screening
- •4. A body weight >50 kg at screening and admission (Day -1 of Period 1)
- •5. Subjects must be fully vaccinated (i.e., have received the full first/second dose[s], as applicable for the vaccine type, plus any recommended booster doses, per current UK guidance) against COVID-19 virus infection at least 12 weeks prior to the admission visit.
- •6. Must agree to adhere to the following required contraception requirements (which are considered to be more conservative than the guidance issued by the Heads of Medicines Agency: Clinical Trials Facilitation Group):
- •6.1. Male subjects with partners of childbearing potential: male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 28 days after last study drug administration. This is longer than 5 half-lives of fenebrutinib (which has been calculated as 3 days) and is in line with contraception requirements in other ongoing fenebrutinib studies.
- •6.2. Male subjects with partners of non-childbearing potential: There is a significant risk of drug exposure through the ejaculate (which also applies to vasectomized males) that might be harmful to sexual partners. Therefore, even if a male is sexually active with a partner of non-childbearing potential, they will be required to use a condom from first administration of IMP until the follow-up phone call.
- •6.3. All male subjects:
- •6.3.1. Alternatively, sexual abstinence is considered a highly effective method of contraception only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- •6.3.2. Male subjects should not donate sperm for the duration of the study and for 28 days after the last study drug administration
- •6.4. Female subjects of non-childbearing potential:
- •6.4.1. Female subjects who are not of childbearing potential do not need to use any methods of contraception
- •6.4.2. Female subjects should not participate in egg donation from dosing, for the duration of the study and for at least 28 days after the last study drug administration
排除标准
- •1. History of serious adverse reaction or serious hypersensitivity to any drug, or sensitivity or intolerance to any ingredient (including excipients) of the fenebrutinib formulations
- •2. Personal or family history of congenital long QT syndrome or family history of sudden death
- •3. Evidence of active infection (with the exception of fungal nail infections or oral herpes) or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening. History of recurrent bacterial, viral, mycobacterial, or fungal infections (defined as >2 similar episodes requiring anti-microbial treatment within the previous 12 months), with the exception of recurrent oral or genital herpes (herpes simplex virus 1/herpes simplex virus 2) or uncomplicated urinary tract infections in females.
- •4. History or evidence of active or latent mycobacterium tuberculosis (TB) infection, regardless of treatment history
- •5. History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, and/or hernia repair will be allowed
- •6. Presence or history of any condition that could possibly affect oral drug absorption
- •7. History of pancreatitis, cholecystectomy or gallstones, or clinically significant GI ulcer or bleeding
- •8. Presence or history of bleeding diathesis
- •9. Presence or history of hepatic diseases or Gilbert’s Syndrome
- •10. History of cancer, including hematologic malignancy and solid tumors, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow-up
- •11. Symptoms of COVID-19 or any other respiratory disease within the 2 weeks prior to admission to the CRU
- •12. Part 3 only: Subject has a medical condition that may adversely affect taste or smell activity
- •13. Evidence of current SARS-CoV-2 (i.e., the virus that causes COVID-19) infection. SARS-CoV-2 antigen testing may be performed based on current infection rates and availability of tests
- •14. Clinically significant abnormal clinical chemistry, hematology, coagulation, or urinalysis result as judged by the Investigator
- •15. Subjects with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia as determined by the Investigator
- •16. Abnormalities in hepatic synthetic function tests (e.g., prothrombin time [PT], international normalized ratio [INR], activated partial thromboplastin time [APTT]) judged by the Investigator to be clinically significant
- •17. Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody [total HBcAb] with detectable hepatitis B virus (HBV) DNA or human immunodeficiency virus (HIV) 1 & 2 antibodies at screening
- •18. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <70 ml/min using the Cockcroft-Gault equation
- •Please see the clinical protocol for the full list of exclusion criteria.
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