Trial Condition(s):

Renal Impairment

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

Bayer Identifier:

18745

ClinicalTrials.gov Identifier:

NCT03235076

EudraCT Number:

2017-001141-28

Study Completed

Trial Purpose

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 dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.

Inclusion Criteria
- 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 Criteria
- 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.

Trial Summary

Enrollment Goal
36
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1101042
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Germany, 24105

Status
Active, not recruiting
 

Trial Design