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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

NCT03235076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-06-05

No results posted yet for this study

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

Interventions

DRUG

BAY1101042

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-11-07
Completion
2019-03-13

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235076 on ClinicalTrials.gov