Status:
COMPLETED
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
Lead Sponsor:
Bayer
Conditions:
Renal Impairment
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to do...
Eligibility Criteria
Inclusion
- Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.
- Age: 18 to 79 years (inclusive) at the screening visit.
- Body mass index (BMI): 18 to 34 kg/m² (both inclusive).
- Male or female subject.
- Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).
- Subjects with renal impairment:
- eGFR \<90 mL/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing.
- Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- Healthy subjects:
- \- eGFR ≥90 mL/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing.
Exclusion
- Pregnant or lactating women.
- Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03235076
Start Date
August 15 2017
End Date
March 13 2019
Last Update
June 5 2023
Active Locations (1)
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1
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany, 24105