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

Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

Sponsors

Lead Sponsor: Bayer

Source Bayer
Brief Summary

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

Overall Status Completed
Start Date March 2011
Completion Date September 2013
Primary Completion Date September 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with adverse events Up to 4 weeks
Secondary Outcome
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
Enrollment 56
Condition
Intervention

Intervention Type: Drug

Intervention Name: BAY85-3934

Description: single dose, 20 mg

Arm Group Label: Arm 1

Intervention Type: Drug

Intervention Name: BAY85-3934

Description: single dose, 40 mg (optional)

Arm Group Label: Arm 2

Intervention Type: Drug

Intervention Name: BAY85-3934

Description: single dose, 80 mg (optional)

Arm Group Label: Arm 3

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
Facility:
Location Countries

Germany

Verification Date

October 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Arm 1

Type: Experimental

Label: Arm 2

Type: Experimental

Label: Arm 3

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov