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

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

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: BAY85-3934; Drug: BAY85-3934; Drug: BAY85-3934

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: BAY85-3934; single dose, 20 mg; Drug: BAY85-3934; single dose, 40 mg (optional); Drug: BAY85-3934; single dose, 80 mg (optional)
EXPERIMENTAL: Arm 2	Drug: BAY85-3934; single dose, 20 mg; Drug: BAY85-3934; single dose, 40 mg (optional); Drug: BAY85-3934; single dose, 80 mg (optional)
EXPERIMENTAL: Arm 3	Drug: BAY85-3934; single dose, 20 mg; Drug: BAY85-3934; single dose, 40 mg (optional); Drug: BAY85-3934; single dose, 80 mg (optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2011
• Primary Completion (ACTUAL): September 5, 2013
• Study Completion (ACTUAL): August 14, 2014

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (ESTIMATE): March 18, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 15557; 2011-000055-16 (EUDRACT_NUMBER)