Renal Impairment Study

NCT03402438 | Completed Phase 1

• 2 other identifiers: 181062017-003301-17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial, Phase I

Outcome Measures

Primary Outcomes (4)

• Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524

  AUC(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC)

  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

• Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524

  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

• AUC of unbound drug (AUCu) of BAY1142524

  AUC (0-tlast) u will be used if mean AUC (tlast ∞) \>20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.

  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

• Cmax of unbound drug (Cmax,u) of BAY1142524

  An additional blood sample for fu will be collected at 2 hours after dosing.

  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 (1)

• Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability

  up to 10 days after dosing

Study Arms (4)

Normal (healthy subjects)

EXPERIMENTAL

Healthy subjects matched for age, body weight and gender to the groups with renal impairment

Drug: Fulacimstat (BAY1142524)

Mildly renal impaired

EXPERIMENTAL

Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m\*2

Drug: Fulacimstat (BAY1142524)

Moderately renal impaired

EXPERIMENTAL

Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m\*2

Drug: Fulacimstat (BAY1142524)

Severely renal impaired

EXPERIMENTAL

Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m\*2

Drug: Fulacimstat (BAY1142524)

Interventions

Fulacimstat (BAY1142524) DRUG

single oral dose of 25 mg immediate-release tablet BAY1142524

Mildly renal impaired; Moderately renal impaired; Normal (healthy subjects); Severely renal impaired

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Interventions

fulacimstat

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: January 11, 2018
• First Posted: January 18, 2018
• Study Start: February 12, 2018
• Primary Completion: December 4, 2018
• Study Completion: March 19, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

DE (1)