check_circleStudy Completed

Renal impairment

Bayer Identifier:

18745

ClinicalTrials.gov Identifier:

NCT03235076

EudraCT Number:

2017-001141-28

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • - 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.
  • - 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
August 2017 - March 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany

Primary Outcome

  • Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
    Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
    date_rangeTime Frame:
    Study Day 1 to Study Day 6
  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
    Maximum observed concentration of BAY1101042 in plasma after single dose administration
    date_rangeTime Frame:
    Study Day 1 to Study Day 6
  • AUCu of BAY1101042
    Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
    date_rangeTime Frame:
    Study Day 1 to Study Day 6
  • Cmax,u of BAY1101042
    Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
    date_rangeTime Frame:
    Study Day 1 to Study Day 6

Trial design

Investigation of pharmacokinetics, safety, tolerability and pharmacodynamic effects of a single oral 10 mg BAY1101042 MR tablet dose in male and female subjects with renal impairment and in age-, gender-, and weight- matched healthy subjects in a single center, non-controlled, open-label, observational design
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
4

Additional Information

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