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

NCT ID: NCT01957657

Last Updated: 2016-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy volunteers group 1

Healthy volunteers with normal renal function

Group Type EXPERIMENTAL

BI 207127

Intervention Type DRUG

oral administration

faldaprevir

Intervention Type DRUG

oral administration

Renal function group 2

Patients with mild renal impairment

Group Type EXPERIMENTAL

BI 207127

Intervention Type DRUG

oral administration

faldaprevir

Intervention Type DRUG

oral administration

Renal function group 3

Patients with moderate renal impairment

Group Type EXPERIMENTAL

BI 207127

Intervention Type DRUG

oral administration

faldaprevir

Intervention Type DRUG

oral administration

Renal function group 4

Patients with severe renal impairment

Group Type EXPERIMENTAL

BI 207127

Intervention Type DRUG

oral administration

faldaprevir

Intervention Type DRUG

oral administration

Interventions

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BI 207127

oral administration

Intervention Type DRUG

faldaprevir

oral administration

Intervention Type DRUG

BI 207127

oral administration

Intervention Type DRUG

BI 207127

oral administration

Intervention Type DRUG

BI 207127

oral administration

Intervention Type DRUG

faldaprevir

oral administration

Intervention Type DRUG

faldaprevir

oral administration

Intervention Type DRUG

faldaprevir

oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1241.32.1 Boehringer Ingelheim Investigational Site

Kiel, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25348520 (View on PubMed)

Other Identifiers

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2013-001075-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.32

Identifier Type: -

Identifier Source: org_study_id

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