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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ketoconazole; Drug: Nintedanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01679613

1199.161

2012-001009-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 34 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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 4 patient groups

1 Nintedanib (Reference)

Experimental group

Description:

single dose, oral with 240 ml water

Treatment:

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

2 Nintedanib + Ketoconazole (Test)

Experimental group

Description:

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

Treatment:

Drug: Ketoconazole

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Drug: Ketoconazole

Drug: Nintedanib

3 Nintedanib (Reference)

Experimental group

Description:

single dose, oral with 240 ml water

Treatment:

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

4 Nintedanib + Ketoconazole (Test)

Experimental group

Description:

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

Treatment:

Drug: Ketoconazole

Drug: Nintedanib

Drug: Nintedanib

Drug: Nintedanib

Drug: Ketoconazole

Drug: Nintedanib