NL-OMON55161已完成不适用
A PHASE I, RANDOMIZED, DOUBLE BLINDED, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF ORAL GDC-8264 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF GDC-8264 IN HEALTHY VOLUNTEERS - GDC-8264 SAD/MAD/FE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
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
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age 18 to 55 years, inclusive
- •- Body mass index between 18 and 30 kg/m2, inclusive
- •- Ability to comply with the study protocol, in the investigator's judgment
- •- Expressed willingness to participate in the entire study
- •- For women of childbearing potential: use contraception as described in
- •For men: use a condom, and agreement to refrain from donating sperm, as
- •defined in protocol
- •- For subjects screened at PRA Health Sciences: meeting of site-specific
- •COVID-19 criteria
排除标准
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •or within 90 days or 5 half-lives of GDC-8264, whichever is longer, after the
- •final dose of study drug
- •- Treatment with investigational therapy within 90 days prior to initiation of
- •- Participation in more than four other drug studies in the 12 months prior to
- •drug administration in the current study
- •- Subjects who have been previously enrolled in this study
- •- Study site employees or immediate family members of a study site or Sponsor
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