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临床试验/NCT07283263
NCT07283263招募中1 期

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年12月23日最近更新:
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干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
106
试验地点
1
主要终点
Number of participants with treatment-emergent adverse events (AEs)
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 purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
  • •Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
  • •For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.

排除标准

  • •Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
  • •Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
  • •Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
  • •Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
  • •Other protocol defined inclusion/exclusion criteria apply.

研究组 & 干预措施

Part B Cohort 11

Experimental

干预措施: Placebo (Other)

Part C

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 1

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 1

Experimental

干预措施: Placebo (Other)

Part A Cohort 2

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 2

Experimental

干预措施: Placebo (Other)

Part A Cohort 3

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 3

Experimental

干预措施: Placebo (Other)

Part A Cohort 4

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 4

Experimental

干预措施: Placebo (Other)

Part A Cohort 5

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 5

Experimental

干预措施: Placebo (Other)

Part A Cohort 6

Experimental

干预措施: BMS-985521 (Drug)

Part A Cohort 6

Experimental

干预措施: Placebo (Other)

Part B Cohort 7

Experimental

干预措施: BMS-985521 (Drug)

Part B Cohort 7

Experimental

干预措施: Placebo (Other)

Part B Cohort 8

Experimental

干预措施: BMS-985521 (Drug)

Part B Cohort 8

Experimental

干预措施: Placebo (Other)

Part B Cohort 9

Experimental

干预措施: BMS-985521 (Drug)

Part B Cohort 9

Experimental

干预措施: Placebo (Other)

Part B Cohort 10

Experimental

干预措施: BMS-985521 (Drug)

Part B Cohort 10

Experimental

干预措施: Placebo (Other)

Part B Cohort 11

Experimental

干预措施: BMS-985521 (Drug)

结局指标

主要结局

Number of participants with treatment-emergent adverse events (AEs)

时间窗: Up to approximately Day 40

Number of participants with treatment-emergent serious adverse events (SAEs)

时间窗: Up to approximately Day 40

Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

时间窗: Up to approximately Day 14

次要结局

  • Elimination Half-Life (T-HALF) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)(Up to approximately Day 14)
  • Maximum Concentration (Cmax) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Time to Cmax (Tmax) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma(Up to approximately Day 14)
  • Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521(Up to approximately Day 14)
  • Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521(Up to approximately Day 14)
  • Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521(Up to approximately Day 14)
  • Geometric Mean Cmax BMS-986521 under fed and fasted conditions(Up to approximately Day 11)
  • Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions(Up to approximately Day 11)
  • Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions(Up to approximately Day 11)
  • Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution(Up to approximately Day 11)
  • Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution(Up to approximately Day 11)
  • Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution(Up to approximately Day 11)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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