Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Raltegravir; Drug: Faldaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785160

2012-004872-21 (EudraCT Number)

1220.65

Details and patient eligibility

About

The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.

Enrollment: 25 patients

Sex: All

Ages: 18 to 50 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: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Raltegravir

Active Comparator group

Description:

coated tablets, oral administration with 240 ml water

Treatment:

Drug: Raltegravir

Drug: Raltegravir

Raltegravir + Faldaprevir

Experimental group

Description:

coated tablets and soft gelatine capsule, oral administration with 240 ml water

Treatment:

Drug: Faldaprevir

Drug: Raltegravir

Drug: Raltegravir