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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: BAY1101042

• Registration Number: NCT03235076
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Study Start: 2017-08-15
• Primary Completion: 2018-11-07
• Study Completion: 2019-03-13
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matched healthy subject group	BAY1101042	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Subjects with severe renal impairment	BAY1101042	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Subjects with mild renal impairment	BAY1101042	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)
Subjects with moderate renal impairment	BAY1101042	Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)

Primary Outcome Measures

Name	Time	Method
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042	Study Day 1 to Study Day 6	Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
AUCu of BAY1101042	Study Day 1 to Study Day 6	Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Cmax,u of BAY1101042	Study Day 1 to Study Day 6	Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042	Study Day 1 to Study Day 6	Maximum observed concentration of BAY1101042 in plasma after single dose administration

Trial Locations

Locations (1)

CRS Clinical-Research-Services Kiel GmbH; 🇩🇪 Kiel, Schleswig-Holstein, Germany