Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin (Avalox®); Drug: BI 207127 placebo; Drug: Faldaprevir; Drug: Faldaprevir placebo; Drug: BI 207127

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965431

2013-002741-11 (EudraCT Number)

1241.40

Details and patient eligibility

About

The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects
• Subjects must be able to understand and comply with study requirements
• Age =18 and =55 years
• BMI range: =18.5 and =29.9 kg/m2

Exclusion criteria

• any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 3 patient groups

BI 207127 + Faldaprevir

Experimental group

Description:

Tablets/capsules

Treatment:

Drug: Faldaprevir

Drug: BI 207127

Moxifloxacin (Avalox®)

Active Comparator group

Description:

Tablets

Treatment:

Drug: Moxifloxacin (Avalox®)

BI 207127 placebo + Faldaprevir placebo

Experimental group

Description:

Tablets/capsules

Treatment:

Drug: Faldaprevir placebo

Drug: BI 207127 placebo