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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957657
• Other study ID #: 1241.32
• Secondary ID: 2013-001075-21
• Status: Completed
• Phase: Phase 1
• First received: October 1, 2013
• Last updated: April 2, 2014
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• BI 207127
oral administration
• faldaprevir
oral administration
• BI 207127
oral administration
• BI 207127
oral administration
• BI 207127
oral administration
• faldaprevir
oral administration
• faldaprevir
oral administration
• faldaprevir
oral administration

Locations

Country	Name	City	State
Germany	1241.32.1 Boehringer Ingelheim Investigational Site	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-infinity (area under the concentration-time curve of BI 207127 in plasma over the time interval from 0 extrapolated to infinity)		up to 10 days	No
Primary	Cmax (maximum measured concentration of BI 207127 in plasma)		up to 10 days	No
Secondary	Number (%) of subjects with drug-related adverse events		up to 18 days	No
Secondary	AUC0-infinity (area under the concentration-time curve of BI 207127 metabolites (CD 6168) in plasma over the time interval from 0 extrapolated to infinity)		up to 10 days	No
Secondary	AUC0-infinity (area under the concentration-time curve of BI 207127 metabolites (BI 208333) in plasma over the time interval from 0 extrapolated to infinity)		up to 10 days	No
Secondary	AUC0-infinity (area under the concentration-time curve of BI 207127 metabolites (CD 6168 acylglucuronide) in plasma over the time interval from 0 extrapolated to infinity)		up to 10 days	No
Secondary	AUC0-infinity (area under the concentration-time curve of BI 207127 metabolites faldaprevir in plasma over the time interval from 0 extrapolated to infinity)		up to 10 days	No
Secondary	Cmax (maximum measured concentration of BI 207127 metabolites (CD 6168) in plasma)		up to 10 days	No
Secondary	Cmax (maximum measured concentration of BI 207127 metabolites (BI 208333) in plasma)		up to 10 days	No
Secondary	Cmax (maximum measured concentration of BI 207127 metabolites (CD 6168 acylglucuronide) in plasma)		up to 10 days	No
Secondary	Cmax (maximum measured concentration of BI 207127 metabolites faldaprevir in plasma)		up to 10 days	No