NCT01318551已完成1 期
Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
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
- Bayer
- 入组人数
- 56
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The informed consent must be signed before any study-specific tests or procedures are done.
- •Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations >30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
- •Male subjects who agree to use 2 forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
- •Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
- •Age: ≥18 and ≤79 years at the pre-study visit.
- •Body mass index (BMI): ≥18 and ≤34 kg/m
- •Ethnicity: white.
- •• Subjects participating in this trial and having received 20 mg BAY 85 3934 are encouraged to participate in the following optionally 40 mg and 80 mg study parts.
- •Ability to understand and follow study-related instructions.
- •For subjects with renal impairment:
- •In diseased subjects: CLCR <90 mL/min determined from a serum creatinine control.
- •In diseased subjects: stable renal disease, ie a serum creatinine value determined at least 3 months before the pre-study visit during routine diagnostics independently of the study should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- •For healthy subjects:
- •Mean age and body weight in Group 1 or Group 6 or Group 11 (control group, healthy subjects) and Groups 2 to 5 and Groups 7 to 10 and Groups 12 to 15 should not vary by more than +10 years and +10 kg, respectively..
- •In diseased subjects: CLCR ≥90 mL/min determined from a serum creatinine control.
排除标准
- •Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).
- •Exclusion periods from other studies or simultaneous participation in other clinical studies.
- •Donation of >100 mL of blood within 4 weeks before the first study drug administration or >500 mL in the preceding 3 months.
- •Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
- •Severe infection or any clinically significant illness within 4 weeks prior to dosing.
- •Known hypersensitivity to the study drugs (active substances, or excipients of the preparations).
- •Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
- •Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus antibodies (HIV 1/2 Ab).
- •Regular use of recreational drugs, eg carnitine products, anabolics.
- •Regular daily consumption of ≥ 0.5 L of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form.
- •Suspicion of drug or alcohol abuse.
- •Positive urine drug screening.
- •Regular daily consumption of >25 cigarettes.
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
- •Use of medication within the 2 weeks preceding the study which could interfere with the investigational product.
- •For subjects with renal impairment:
- •Acute renal failure.
- •Acute nephritis.
- •Nephrotic syndrome.
- •Any organ transplant < 1 year before participation in this study.
- •Failure of any other major organ system other than the kidney.
- •Relevant impairment in liver function of by option of the investigator.
- •Pre-existing diseases for which it can be assumed that the absorption of the study drugs will not be normal (ie relevant malabsorption, chronic diarrhea).
- •Diastolic blood pressure (DBP) >100 mmHg and/or systolic blood pressure (SBP) >180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any).
- •Heart rate <45 or >100 BPM for subject aged 18 to ≤50 years and <55 or >110 BPM for subject aged >50 to ≤79 years at screening visit.
- •Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree AV block without a cardiac pacemaker or episodes of sustained ventricular tachycardia, or by option of the investigator.
- •Diagnosed malignancy within the past 5 years.
- •Psychiatric disorders which may disable the subjects to consent.
- •Change in chronic medications <4 weeks prior to dosing.
- •Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications.
- •For healthy subjects
- •Subjects with conspicuous findings in medical history or pre-study examination by option of the investigator.
- •A history of relevant diseases of vital organs, of the central nervous system or other organs.
- •Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- •Systolic blood pressure <100 mmHg or >145 mmHg.
- •Diastolic blood pressure >95 mmHg.
- •Heart rate <45 or >95 BPM for subject aged 18 to ≤50 years and <55 or >95 BPM for subject aged >50 to ≤79 years at screening visit.
- •Clinically relevant findings in the ECG such as a second- or third-degree AV block, clinically relevant prolongation of the QRS complex >120 ms or of the QTc interval >450 ms for men and >470 ms for women of by option of the investigator.
- •Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range of by option of the investigator.
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY85-3934 (Drug)
Arm 2
Experimental
干预措施: BAY85-3934 (Drug)
Arm 3
Experimental
干预措施: BAY85-3934 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 4 weeks
次要结局
- Peak Plasma Concentration (Cmax) of BAY85-3934(Day 0 to day 4)
- Dose-normalized area under the plasma concentration-time curve (AUCnorm) of BAY85-3934(Day 0 to day 4)
- Dose- and body weight-normalised Cmax (Cmax-norm) of BAY85-3934(Day 0 to day 4)
- Area under the plasma concentration versus time curve (AUC) of BAY85-3934(Day 0 to day 4)
研究者
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