Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Oral Doses of BAY 2395840 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY 2395840 in Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events
研究概览
简要总结
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans.
In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men.
All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2.
The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks.
During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent.
- •Body mass index (BMI) ≥18 kg/m^2 and ≤30 kg/m^
- •Participants who are overtly healthy.
- •Race: White.
- •Male participants of reproductive potential who are sexually active must agree to use contraception methods.
排除标准
- •Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
- •Any known disease that was forbidden in the study as specified in study protocol.
- •Any medication or drug use that was forbidden in the study as specified in study protocol.
- •Any abnormal finding in Electrocardiogram (ECG), blood pressure or heart rate.
- •Any clinical relevant deviation from normal range of laboratory parameters at screening.
- •History of COVID-
- •Prior contact with SARS-CoV-2 positive person or COVID-19 patient within the last 4 weeks prior admission to the ward.
- •Positive SARS-CoV-2 viral RNA test.
研究组 & 干预措施
Group 8
Participants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions
干预措施: BAY2395840 tablet (Drug)
Group 6
Participants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions
干预措施: BAY2395840 tablet (Drug)
Group 7
Participants received BAY2395840 dose I as tablets under diet 1 conditions
干预措施: BAY2395840 tablet (Drug)
Group 1
Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2)
干预措施: BAY2395840 tablet (Drug)
Group 1
Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2)
干预措施: BAY2395840 oral solution (Drug)
Group 2
Participants received BAY2395840 dose C as tablets under diet 1 conditions.
干预措施: BAY2395840 tablet (Drug)
Group 3
Participants received BAY2395840 dose E as tablets under diet 1 conditions.
干预措施: BAY2395840 tablet (Drug)
Group 4
Participants received BAY2395840 dose H as tablets under diet 1 conditions
干预措施: BAY2395840 tablet (Drug)
Group 5
Participants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions
干预措施: BAY2395840 tablet (Drug)
Placebo matching Group 1
Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2)
干预措施: Placebo oral solution (Drug)
Placebo matching Group 1
Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2)
干预措施: Placebo tablet (Drug)
Placebo matching Group 2 to 4 and Group 7
Participants received a dose of Placebo as tablets under diet 1 conditions
干预措施: Placebo tablet (Drug)
Placebo matching Group 5 and 6
Participants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions
干预措施: Placebo tablet (Drug)
Placebo matching Group 8
Participants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions.
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events
时间窗: Up to 14 days after end of treatment with study medication in the respective period.
Number of participants with treatment-emergent adverse events, categorized by severity.
时间窗: Up to 14 days after end of treatment with study medication in the respective period.
次要结局
- Maximum observed drug concentration in plasma (Cmax) after multiple doses of BAY2395840(Predose up to 192 hours)
- Maximum observed drug concentration in plasma (Cmax) after single dose of BAY2395840(Predose up to 192 hours)
- Area under the plasma concentration-time curve from zero to 24 hours AUC (0-24) after single dose of BAY2395840(Pre-dose and up to 24 hours post dose)
- Area under the plasma concentration-time curve over the last 24-h dosing interval AUC(0-24)in plasma after multiple doses of BAY2395840(Pre-dose and up to 24 hours post dose)
- Area under the concentration vs. time curve from zero to infinity (AUC) in plasma after single dose of BAY2395840(Predose up to 192 hours)