Anemia
Conditions
Keywords
Anemia
Brief summary
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
Interventions
DRUGBAY85-3934
single dose, 20 mg
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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 \<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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of BAY85-3934 | Day 0 to day 4 |
| 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 |
Countries
Germany
Outcome results
None listed