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Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

NCT01825980 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-02-21

No results posted yet for this study

Summary

To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.

Conditions

  • Hepatitis C

Interventions

DRUG

BZF961

There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.

DRUG

Ritonavir

Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825980 on ClinicalTrials.gov