临床试验/NCT07566130

NCT07566130已完成1 期

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Ascending Oral Doses of Nacresertib in Healthy Adult Subjects

AbbVie1 个研究点分布在 1 个国家目标入组 93 人开始时间: 2025年4月18日最近更新: 2026年6月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 93
试验地点: 1
主要终点: Maximum Observed Plasma Concentration (Cmax) of nacresertib

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objectives for this 2 Part study are to assess the safety, tolerability, and pharmacokinetics following single ascending oral doses of nacresertib in healthy adult participants (Part 1) and to assess the safety, tolerability, and pharmacokinetics following multiple ascending oral doses in healthy adult participants (Part 2).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•-- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.

排除标准

•History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
•History of any clinically significant sensitivity or allergy to any medication or food.
•History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.]

研究组 & 干预措施

Part 1: Dose A

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 1: Dose B

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 1: Dose B

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 2: Dose G

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 2: Dose G

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 1: Dose D

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 1: Dose D

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 1: Dose E

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 1: Dose E

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 2: Dose F

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 2: Dose F

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 2: Dose H

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 2: Dose H

Experimental

Participants will receive multiple doses of nacresertib or Placebo

干预措施: Placebo (Drug)

Part 1: Dose A

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 1: Dose C

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: nacresertib (Drug)

Part 1: Dose C

Experimental

Participants will receive a single dose of nacresertib or Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Maximum Observed Plasma Concentration (Cmax) of nacresertib

时间窗: Up to Day 19

Cmax of nacresertib

Time to Cmax (Tmax) of nacresertib

时间窗: Up to Day 19

Tmax of nacresertib

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of nacresertib

时间窗: Up to Day 19

AUCt of nacresertib

AUC From Time 0 to the Time Infinity (AUCinf) of nacresertib

时间窗: Up to Day 19

AUCinf of nacresertib

Part 2 Only: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of nacresertib

时间窗: Up to Day 14

AUCtau of nacresertib

Terminal Phase Elimination Rate Constant (Beta) of nacresertib

时间窗: Up to Day 19

Beta of nacresertib

Terminal Phase Elimination Half-Life (t1/2) of nacresertib

时间窗: Up to Day 19

t1/2 of nacresertib

Dose Normalized Cmax

时间窗: Up to Day 19

Dose Normalized Cmax

Dose Normalized AUCs

时间窗: Up to Day 19

Dose Normalized AUCs

Number of Participants Experiencing Adverse Events (AEs)

时间窗: 74 Days

Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment

次要结局

未报告次要终点

研究者

发起方

AbbVie

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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