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

Phase 1

Completed

• Conditions: Anemia
• Interventions: Drug: BAY85-3934

• Registration Number: NCT01318551
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-10
• Study Start: 2011-03-16
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2013-09-05
• Study Completion: 2014-08-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY85-3934	-
Arm 2	BAY85-3934	-
Arm 3	BAY85-3934	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
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
Area under the plasma concentration versus time curve (AUC) of BAY85-3934	Day 0 to day 4