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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235076
• Other study ID #: 18745
• Secondary ID: 2017-001141-28
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2017
• Est. completion date: March 13, 2019

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 13, 2019
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• BAY1101042
Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)

Locations

Country	Name	City	State
Germany	CRS Clinical-Research-Services Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study Day 1 to Study Day 6
Primary	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	Study Day 1 to Study Day 6
Primary	AUCu of BAY1101042	Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042	Study Day 1 to Study Day 6
Primary	Cmax,u of BAY1101042	Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042	Study Day 1 to Study Day 6