NCT07726914尚未招募1 期
An Open-label, Randomized, Phase 1, 2-treatment, 2-period, 2-sequence, Cross-over, Bioequivalence Study Comparing Belumosudil Oral Suspension (Test Formulation) With Belumosudil Tablet (Commercially Available Reference Formulation) in Healthy Adult Male Participants Under Fed Condition
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 58
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants aged 18 to 45 years, inclusive.
Study details include:
The study duration will be approximately 40 days. The treatment period will be up to 8 days. At least 3 days post-treatment follow-up period. end of study: 6±1 days from the last dose. The number of visits will be 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participant between 18 to 45 years of age, inclusive
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Body weight between 50.0 and 115.0 kg, inclusive, and BMI between 18.0 and 32.0 kg/m2, inclusive
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Capable of giving signed informed consent
排除标准
- •, participants are excluded from the study if any of the following criteria apply:
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •Blood donation (usually approximately 500 mL) within 2 months before inclusion
- •Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP ≥30 mmHg within 3 minutes when changing from supine to standing position
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician
- •History or current presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). Medically prescribed cannabis is not allowed
- •Smoking regularly more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking (occasional smoker can be enrolled)
- •Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
- •Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicaemia) within the 3 months or 90 days prior to screening
- •Known or suspected malignancy, autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status or any factor that would predispose participants to develop infection (eg, open skin lesion, recurrent issue related to poor dentition, perianal fissures, history of splenectomy, primary immunodeficiency)
- •Any medication (including proton pump inhibitors, CYP3A inducers or strong and moderate CYP3A inhibitors, St John's Wort, or ginseng) within 14 days before study treatment administration or 5 half-lives, whichever is longer
- •Use of any herbal medicines within 2 weeks before each IMP administration and up to the end of PK sampling following the IMP administration
- •Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion
- •Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 90 days or 5 half-lives whichever is longer, before inclusion in this clinical study
- •Positive result on any of the following tests: HBs Ag, anti-HBc Ab (total or IgM), anti-HCV antibodies, anti-HIV 1 and 2 antibodies
- •Confirmed positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
- •Confirmed positive alcohol breath test
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
AUClast
时间窗: Baseline (H0) to Day 3 (H48) for each of the 2 periods
Area under the plasma concentration versus time curve until the time of last quantifiable concentration
Cmax
时间窗: Baseline (H0) to Day 3 (H48) for each of the 2 periods
Maximum plasma concentration observed
次要结局
- tmax(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
- t1/2z(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
- tlag(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
- AUC(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
- AUClast/AUC(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
- λz(Baseline (H0) to Day 3 (H48) for each of the 2 periods)
研究者
相似试验
已完成
1 期
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release TabletsType 2 Diabetes Mellitus (T2DM)Cardiovascular DiseasesNCT07691203Humanis Saglık Anonim Sirketi36
尚未招募
不适用
A study to compare the bioavailability of Nutrabay BioAbsorb Whey and Whey Protein in healthy adults under fasting conditions.CTRI/2025/08/093909Nutrabay Retail Pvt. Ltd.24
进行中（未招募）
不适用
Bioequivalence study in Adult Male and Female Patients with Ovarian Cancer or Breast Cancer or Prostate Cancer Under Fasting Condition.CTRI/2025/01/079400Biocon Pharma Limited14
招募中
不适用
Risperidone patient population study to establish bioequivalenceCTRI/2024/09/073270Amneal EU Limited110
尚未招募
不适用
Bioequivalence study of Sitagliptin 50 mg and Metformin Hydrochloride 500 mg Extended release tablets in healthy adult human subjects under fed conditions.CTRI/2024/10/075543Sunglow Lifescience Private Limited32