NCT03235076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

July 28, 2017

Last Update Submit

June 2, 2023

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

Subjects with mild renal impairment

EXPERIMENTAL

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

Drug: BAY1101042

Subjects with moderate renal impairment

EXPERIMENTAL

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

Drug: BAY1101042

Subjects with severe renal impairment

EXPERIMENTAL

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

Drug: BAY1101042

Matched healthy subject group

EXPERIMENTAL

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

Drug: BAY1101042

Interventions

BAY1101042DRUG

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

Matched healthy subject groupSubjects with mild renal impairmentSubjects with moderate renal impairmentSubjects with severe renal impairment

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 1, 2017

Study Start

August 15, 2017

Primary Completion

November 7, 2018

Study Completion

March 13, 2019

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

DE(1)