ISRCTN16366416已完成1 期
A phase I, open-label, single-dose, fixed-sequence, two-part study to evaluate the effect of itraconazole and carbamazepine on giredestrant pharmacokinetics in healthy female subjects of non-childbearing potential
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Genentech
- 入组人数
- 33
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
- Female
入选标准
- •1. Females of non-childbearing potential and either postmenopausal and with a negative pregnancy test result at screening (serum test) and check-in (Day -1; urine test) of Period 1.
- •2. Females with body mass index (BMI) range 18.5 to 32.0 kilograms per meter square (kg/m2), inclusive, at screening.
- •3. Females in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs.
- •4. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens.
排除标准
- •1. Female participant with a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator).
- •2. History of stomach or intestinal surgery (including cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair were allowed (unless performed within 12 months prior to screening).
- •3. Malabsorption syndrome or other condition that would interfere with enteral absorption.
- •4. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance < 70 milliliters/minute (mL/min) using the Cockcroft-Gault equation.
- •5. History of active or latent tuberculosis (TB), regardless of treatment history, or positive QuantiFERON TB Gold test.
- •6. History of previous use of tamoxifen, aromatase inhibitors, giredestrant, or any other endocrine agent for the treatment of breast cancer.
- •7. The use of hormone replacement therapy or selective estrogen receptor (ER) modulators (selective estrogen receptor modulators (SERMs); e.g., raloxifene) within 1 year prior to Check-in (Day -1) or
- •8. The use of oral antibiotics within 4 weeks or intravenous (IV) antibiotics within 8 weeks prior to check-in (Day -1).
- •9. Use of any moderate or strong cytochrome P450 (CYP3A) inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day-1).
- •10. The use or intent to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John’s wort, within 30 days prior to Check-in (Day -1).
- •11. Female subject having a history of any malignancy, within 5 years prior to screening.
- •12. Positive for the human leukocyte antigen-B (HLA-B*1502) allele (Part B only).
研究者
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