| Eligibility |
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.
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