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

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ClinicalTrials.gov Identifier: NCT01957657
Recruitment Status : Terminated
First Posted : October 8, 2013
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: BI 207127 Drug: faldaprevir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy volunteers group 1
Healthy volunteers with normal renal function
 Drug: BI 207127
oral administration

Drug: faldaprevir
oral administration
Experimental: Renal function group 2
Patients with mild renal impairment
 Drug: BI 207127
oral administration

Drug: faldaprevir
oral administration
Experimental: Renal function group 3
Patients with moderate renal impairment
 Drug: BI 207127
oral administration

Drug: faldaprevir
oral administration
Experimental: Renal function group 4
Patients with severe renal impairment
 Drug: BI 207127
oral administration

Drug: faldaprevir
oral administration


Outcome Measures
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Primary Outcome Measures :
  1. AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity) [ Time Frame: Day 4 ]
    Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  2. Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.


Secondary Outcome Measures :
  1. Number (%) of Subjects With Drug-related Adverse Events [ Time Frame: From the first drug administration until last drug administration, up to 10 days ]
    Number (percentage) of subjects with drug-related adverse events

  2. 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) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  3. 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) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  4. 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) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  5. AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  6. Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  7. Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  8. Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.

  9. Cmax (Maximum Measured Concentration of Faldaprevir in Plasma) [ Time Frame: Day 4 ]
    Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957657


Locations
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Germany
1241.32.1 Boehringer Ingelheim Investigational Site
Kiel, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01957657    
Other Study ID Numbers: 1241.32
2013-001075-21 ( EudraCT Number: EudraCT )
First Posted: October 8, 2013    Key Record Dates
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases