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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Rifampicin
Drug: Nintedanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01770392
2012-002507-18 (EudraCT Number)
1199.162

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Healthy male subjects

Exclusion criteria

  1. Any relevant deviation from healthy conditions

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Test
Active Comparator group
Description:
multiple doses of Rifampicin + single dose of Nintedanib
Treatment:
Drug: Rifampicin
Drug: Nintedanib
Drug: Nintedanib
Reference
Experimental group
Description:
single dose of Nintedanib
Treatment:
Drug: Nintedanib
Drug: Nintedanib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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