NCT05684289已完成1 期
A Phase 1, 2-Part, Randomized, Double-Blind, Placebo-controlled, Multiple Dose Study to Test the Potential Interaction of a PDE5 Inhibitor With BMS-986278 and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986278 in Healthy Adult Participants (Part 1) and in Japanese Participants (Part 2)
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese).
- •Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^
- •Body weight ≥ 50 kg for males and ≥ 45 kg for females.
排除标准
- •Any significant acute or chronic medical illness.
- •Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion.
- •Any major surgery within 4 weeks of first study intervention administration.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: BMS-986278 + Sildenafil
Experimental
干预措施: BMS-986278 (Drug)
Part 1: BMS-986278 + Sildenafil
Experimental
干预措施: Sildenafil (Drug)
Part 1: Placebo + Sildenafil
Placebo Comparator
干预措施: Sildenafil (Drug)
Part 1: Placebo + Sildenafil
Placebo Comparator
干预措施: Placebo (Drug)
Part 2: BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
Part 2: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
时间窗: Up to 16 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
时间窗: Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
时间窗: Up to 14 days
Maximum observed plasma concentration (Cmax) (Part 2)
时间窗: Up to 14 days
次要结局
- Number of participants with serious adverse events (SAEs) (Part 1 and 2)(30 days after last dose)
- Number of participants with clinical laboratory abnormalities (Part 1 and 2)(30 days after last dose)
- AUC(0-T) (Part 1)(Up to 16 days)
- Number of participants with vital sign abnormalities (Part 1 and 2)(30 days after last dose)
- Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)(30 days after last dose)
- Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)(30 days after last dose)
- Cmax (Part 1 and 2)(Up to 16 days)
- Number of participants with physical examination abnormalities (Part 1 and 2)(30 days after last dose)
- Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)(Up to 14 days)
- Tmax (Part 1)(Up to 16 days)
- Number of participants with adverse events (AEs) (Part 1 and 2)(30 days after last dose)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)Heart FailureNCT06122779Bristol-Myers Squibb227
已完成
1 期
A Study of the Safety, Blood Levels and Biological Effects of GBT440 in Healthy Subjects and Subjects With Sickle Cell DiseaseHealthy SubjectsSickle Cell DiseaseNCT02285088Global Blood Therapeutics133
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic DermatitisDermatitis, AtopicNCT06248814Bristol-Myers Squibb64
进行中（未招募）
1 期
Study of BMN 349 Single Dose in PiZZ and PiMZ/MASH Adult ParticipantsAlpha 1-Antitrypsin DeficiencyNCT06738017BioMarin Pharmaceutical6
撤回
1 期
A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT05240300BiomX, Inc.48