Trial Condition(s):
Single dose group stratified study in renal impaired and healthy aged and gender matched subjects
15557
Not Available
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
- 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/m2. - 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.
- 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.
Locations | Status | |
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Locations Investigative Site Kiel, Germany, 24105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
3