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

Bayer1 site in 1 country36 target enrollmentAugust 15, 2017

ConditionsRenal Impairment

InterventionsBAY1101042

DrugsBAY1101042

Overview

Phase: Phase 1
Intervention: BAY1101042
Conditions: Renal Impairment
Sponsor: Bayer
Enrollment: 36
Locations: 1
Primary Endpoint: Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2017

End Date

March 13, 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

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.