Clinical trial NCT01957657: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: Day 4
measure: Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)
timeFrame: Day 4
Secondary outcomes:
measure: Number (%) of Subjects With Drug-related Adverse Events
timeFrame: From the first drug administration until last drug administration, up to 10 days
measure: AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: Day 4
measure: AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: Day 4
measure: AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: Day 4
measure: AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
timeFrame: Day 4
measure: Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)
timeFrame: Day 4
measure: Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)
timeFrame: Day 4
measure: Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)
timeFrame: Day 4
measure: Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)
timeFrame: Day 4
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: 1241.32.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Huang F, Moschetti V, Lang B, Halabi A, Petersen-Sylla M, Yong CL, Elgadi M. Pharmacokinetics, safety, and tolerability of faldaprevir in patients with renal impairment. Antimicrob Agents Chemother. 2015 Jan;59(1):251-7. doi: 10.1128/AAC.03359-14. Epub 2014 Oct 27.