NCT01814709已完成1 期
A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Pharmacokinetics: Plasma concentrations of GDC-0032
研究概览
简要总结
This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers will receive GDC-0032 and itraconazole. The anticipated time on study treatment is approximately 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female volunteers will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile
- •Male volunteers will either be sterile, or agree to use adequate methods of contraception
- •Body mass index (BMI) range 18 to 32 kg/m2, inclusive
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs; and clinical laboratory evaluations
- •Negative hepatitis B virus, hepatitis C virus and negative HIV antibody screens
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- •History of stomach or intestinal surgery or resection that would alter absorption and/or excretion of orally administered study drugs
- •History of alcoholism or drug addiction within 1 year prior to Check-in
- •History of chronic proton pump inhibitor (PPI) use within 6 months of Check-in, or use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to Check-in and during the entire study
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •History type 1 or 2 diabetes and/or elevated fasting glucose at baseline
- •Malabsorption syndrome or other condition that would interfere with enteral absorption
- •Use of any tobacco- or nicotine containing- products
- •Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer to Check-in and during the entire study duration
研究组 & 干预措施
Itraconazole Arm
Experimental
干预措施: Itraconazole (Drug)
Rifampin Arm
Experimental
干预措施: Rifampin (Drug)
Itraconazole Arm
Experimental
干预措施: GDC-0032 (Drug)
Rifampin Arm
Experimental
干预措施: GDC-0032 (Drug)
结局指标
主要结局
Pharmacokinetics: Plasma concentrations of GDC-0032
时间窗: 2 months
Safety: Incidence of adverse events
时间窗: 2 months
次要结局
未报告次要终点
研究者
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