Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Atorvastatin; Drug: Faldaprevir; Drug: Itraconazole; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795937

2012-005518-20 (EudraCT Number)

1220.61

Details and patient eligibility

About

To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin

Enrollment: 51 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female 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)

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51 participants in 2 patient groups

Part 1: Faldaprevir + Itraconazole

Experimental group

Description:

Interaction of Faldaprevir and Itraconazole

Treatment:

Drug: Faldaprevir

Drug: Faldaprevir

Drug: Itraconazole

Part 2:Faldaprevir+Rosuvastatin+Atorvast

Experimental group

Description:

Interaction of Faldaprevir, Rosuvastatin and Atorvastatin

Treatment:

Drug: Rosuvastatin

Drug: Atorvastatin

Drug: Faldaprevir

Drug: Faldaprevir