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

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