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Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

NCT ID: NCT01679613

Last Updated: 2014-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Nintedanib (Reference)

single dose, oral with 240 ml water

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

low dose oral administration

2 Nintedanib + Ketoconazole (Test)

Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Group Type EXPERIMENTAL

Ketoconazole

Intervention Type DRUG

oral administration

Nintedanib

Intervention Type DRUG

low dose oral administration

3 Nintedanib (Reference)

single dose, oral with 240 ml water

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

low or medium dose depending on pilot part

4 Nintedanib + Ketoconazole (Test)

Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

low or medium dose depending on pilot part

Ketoconazole

Intervention Type DRUG

oral administration

Interventions

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Nintedanib

low or medium dose depending on pilot part

Intervention Type DRUG

Nintedanib

low dose oral administration

Intervention Type DRUG

Ketoconazole

oral administration

Intervention Type DRUG

Nintedanib

low dose oral administration

Intervention Type DRUG

Nintedanib

low or medium dose depending on pilot part

Intervention Type DRUG

Ketoconazole

oral 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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1199.161.1 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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2012-001009-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.161

Identifier Type: -

Identifier Source: org_study_id