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

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: faldaprevir; Drug: BI 207127

Study type: Interventional

Funder types: Industry

Identifiers

NCT01957657

2013-001075-21 (EudraCT Number)

1241.32

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 4 patient groups

Healthy volunteers group 1

Experimental group

Description:

Healthy volunteers with normal renal function

Treatment:

Drug: faldaprevir

Drug: faldaprevir

Drug: BI 207127

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Renal function group 2

Experimental group

Description:

Patients with mild renal impairment

Treatment:

Drug: faldaprevir

Drug: faldaprevir

Drug: BI 207127

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Renal function group 3

Experimental group

Description:

Patients with moderate renal impairment

Treatment:

Drug: faldaprevir

Drug: faldaprevir

Drug: BI 207127

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Renal function group 4

Experimental group

Description:

Patients with severe renal impairment

Treatment:

Drug: faldaprevir

Drug: faldaprevir

Drug: BI 207127

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127

Drug: faldaprevir

Drug: BI 207127