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

Phase 2

Terminated

• Conditions: Hepatitis C
• Interventions: Drug: LCQ908; Drug: Placebo

• Registration Number: NCT01387958
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCQ908	LCQ908	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Measure: Change in hepatitis C viral load as assessed by PCR	2 weeks

Secondary Outcome Measures

Name	Time	Method
Measure: LCQ908 concentrations in the blood	over 21 days
Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.	28 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇿 Christchurch, New Zealand