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

• Status: Completed
• Trial end date: 2019-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

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.