A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hepatitis C

Treatments: Drug: LCQ908; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387958

CLCQ908A2214

Details and patient eligibility

About

This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent.
• Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
• No prior therapy or inadequate response to therapy for hepatitis C.
• Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.

Exclusion criteria

• Use of other investigational drugs within at least 30 days of enrollment
• Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

LCQ908

Experimental group

Treatment:

Drug: LCQ908

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo