Clinical trial NCT03402438: Renal Impairment Study
Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR 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: Clinical Trial, Phase I
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-18
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: The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
* Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels \>40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
* 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.

Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).

Exclusion Criteria:

* Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
* Relevant impairment in liver function.
* Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
* Any organ transplant \< 1 year before participation in this study.
* Subject under dialysis or planned to start dialysis during participation in the study.
* Failure of any other major organ system other than the kidney.

Primary outcomes:
measure: Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524
timeFrame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524
timeFrame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
measure: AUC of unbound drug (AUCu) of BAY1142524
timeFrame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
measure: Cmax of unbound drug (Cmax,u) of BAY1142524
timeFrame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Secondary outcomes:
measure: Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
timeFrame: up to 10 days after dosing
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: