Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 207127 + faldaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737996

2012-003697-10 (EudraCT Number)

1241.35

Details and patient eligibility

About

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

Enrollment: 32 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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32 participants in 1 patient group

All patients

Experimental group

Description:

For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir

Treatment:

Drug: BI 207127 + faldaprevir