NCT05878704终止1 期
A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Concentration of GBT021601 in whole blood and plasma
研究概览
简要总结
Renal Impairment study of GBT021601.
详细描述
This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ≥ 18 years of age at the time of Screening.
- •Have liver (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and total bilirubin [direct and indirect]) and renal function tests, Hb, and hematocrit values within normal limits or are not clinically significant at Screening and Day -1 (Cohort 2 only).
- •Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.
排除标准
- •Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant.
- •Evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.
研究组 & 干预措施
Treatment
Experimental
GBT021601
干预措施: GBT021601 (Drug)
结局指标
主要结局
Concentration of GBT021601 in whole blood and plasma
时间窗: Up to 112 Days
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Single-dose PK parameters
时间窗: Up to 112 Days
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
次要结局
- Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs(Up to 112 Days)
研究者
研究点 (3)
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