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Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin

NCT ID: NCT01770392

Last Updated: 2014-11-27

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib

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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Test

multiple doses of Rifampicin + single dose of Nintedanib

Group Type ACTIVE_COMPARATOR

Rifampicin

Intervention Type DRUG

single dose once daily for 7 days

Nintedanib

Intervention Type DRUG

single dose administration

Reference

single dose of Nintedanib

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

single dose administration

Interventions

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Nintedanib

single dose administration

Intervention Type DRUG

Rifampicin

single dose once daily for 7 days

Intervention Type DRUG

Nintedanib

single dose administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male subjects

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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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1199.162.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

References

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Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.

Reference Type DERIVED
PMID: 29500603 (View on PubMed)

Other Identifiers

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2012-002507-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.162

Identifier Type: -

Identifier Source: org_study_id