single dose group stratified study in renal impaired and healthy aged and gender matched subjects

Conditions: Anemia

Summary: safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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 \ 100 bpm for subject aged 18 to ≤50 years and \ 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 \ 145 mmhg. * diastolic blood pressure \>95 mmhg. * heart rate \ 95 bpm for subject aged 18 to ≤50 years and \ 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.

Keywords: anemia