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Completed

NCT Number: NCT03235076

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY1101042

Drug

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

Primary outcomes

  1. Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042

    Time frame: Study Day 1 to Study Day 6

    Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042

  2. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042

    Time frame: Study Day 1 to Study Day 6

    Maximum observed concentration of BAY1101042 in plasma after single dose administration

  3. AUCu of BAY1101042

    Time frame: Study Day 1 to Study Day 6

    Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042

  4. Cmax,u of BAY1101042

    Time frame: Study Day 1 to Study Day 6

    Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 1, 2017
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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