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 logo

Bayer

Status and phase

Completed
Phase 1

Conditions

Renal Impairment

Treatments

Drug: BAY1101042

Study type

Interventional

Funder types

Industry

Identifiers

NCT03235076
18745
2017-001141-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

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 design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 4 patient groups

Subjects with mild renal impairment
Experimental group
Description:
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Treatment:
Drug: BAY1101042
Subjects with moderate renal impairment
Experimental group
Description:
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Treatment:
Drug: BAY1101042
Subjects with severe renal impairment
Experimental group
Description:
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Treatment:
Drug: BAY1101042
Matched healthy subject group
Experimental group
Description:
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Treatment:
Drug: BAY1101042

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems