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

NCT ID: NCT01318551

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-16
• Study Completion Date: 2014-08-14

Brief Summary

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

Conditions

Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

single dose, 20 mg

Arm 2

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

single dose, 40 mg (optional)

Arm 3

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

single dose, 80 mg (optional)

Interventions

BAY85-3934

single dose, 20 mg

Intervention Type: DRUG

BAY85-3934

single dose, 40 mg (optional)

Intervention Type: DRUG

BAY85-3934

single dose, 80 mg (optional)

Intervention Type: DRUG

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 <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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

2011-000055-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15557

Identifier Type: -

Identifier Source: org_study_id