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Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

NCT ID: NCT01737996

Last Updated: 2016-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

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The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir

Group Type EXPERIMENTAL

BI 207127 + faldaprevir

Intervention Type DRUG

fixed dose combination

Interventions

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BI 207127 + faldaprevir

fixed dose combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. healthy male and female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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1241.35.1 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-003697-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.35

Identifier Type: -

Identifier Source: org_study_id

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