Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects

• Status: Completed
• Trial end date: 2014-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

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 <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.