Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
timeFrame: Study Day 1 to Study Day 6
measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
timeFrame: Study Day 1 to Study Day 6
measure: AUCu of BAY1101042
timeFrame: Study Day 1 to Study Day 6
measure: Cmax,u of BAY1101042
timeFrame: Study Day 1 to Study Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical-Research-Services Kiel GmbH
state: Schleswig-Holstein
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: