Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Single Center, Open-label, Parallel-group, Phase I Trial

The objective of the trial is to investigate the effect of different degrees of renal impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and faldaprevir on day 4.

Inclusion criteria:

• Healthy volunteers (males and females) or patients with impaired renal function (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good health as determined by past medical history, physical examination, vital signs, ECG and laboratory assessments (aside from abnormalities specific for renal impairment)
• Age from 18 to 79 years
• Subjects must be able to understand and comply with study requirements

Exclusion criteria:

• Any relevant deviation from healthy conditions for healthy volunteers

• Subjects with significant diseases other than renal impairment will be excluded. A significant disease is defined as a disease which in the opinion of the investigator:

  • put the patient at risk because of participation in the study
  • may influence the results of the study
  • may influence the patients ability to participate in the study
  • is not in a stable condition

• Diabetic or hypertensive patients can be entered in this trial if the disease is not significant according to these criteria