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

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)

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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