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

NCT ID: NCT03235076

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2019-03-13

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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects with mild renal impairment

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

Group Type: EXPERIMENTAL

BAY1101042

Intervention Type: DRUG

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

Subjects with moderate renal impairment

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

Group Type: EXPERIMENTAL

BAY1101042

Intervention Type: DRUG

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

Subjects with severe renal impairment

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

Group Type: EXPERIMENTAL

BAY1101042

Intervention Type: DRUG

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

Matched healthy subject group

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

Group Type: EXPERIMENTAL

BAY1101042

Intervention Type: DRUG

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

Interventions

BAY1101042

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

2017-001141-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18745

Identifier Type: -

Identifier Source: org_study_id