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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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY1101042

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

CRS Clinical-Research-Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Subjects with mild renal impairment

Subjects with moderate renal impairment

Subjects with severe renal impairment

Matched healthy subject group

Arm Description

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Outcomes

Primary Outcome Measures

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

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

AUCu of BAY1101042

Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042

Cmax,u of BAY1101042

Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042

Secondary Outcome Measures

Full Information

NCT ID

NCT03235076

First Posted

July 28, 2017

Last Updated

June 2, 2023

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03235076

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 15, 2017 (Actual)

Primary Completion Date

November 7, 2018 (Actual)

Study Completion Date

March 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with mild renal impairment

Arm Type

Experimental

Arm Description

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Arm Title

Subjects with moderate renal impairment

Arm Type

Experimental

Arm Description

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Arm Title

Subjects with severe renal impairment

Arm Type

Experimental

Arm Description

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Arm Title

Matched healthy subject group

Arm Type

Experimental

Arm Description

Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Intervention Type

Drug

Intervention Name(s)

BAY1101042

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042

Description

Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042

Time Frame

Study Day 1 to Study Day 6

Title

Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042

Description

Maximum observed concentration of BAY1101042 in plasma after single dose administration

Time Frame

Study Day 1 to Study Day 6

Title

AUCu of BAY1101042

Description

Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042

Time Frame

Study Day 1 to Study Day 6

Title

Cmax,u of BAY1101042

Description

Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042

Time Frame

Study Day 1 to Study Day 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical-Research-Services Kiel GmbH

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

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