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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03235076

Enrollment

Registered

2017-08-01

Start date

2017-08-15

Completion date

2019-03-13

Last updated

2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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 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.

Interventions

DRUGBAY1101042

Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026