Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection

NCT02254707 | Completed Phase 1

• 1 other identifier: 1201.14
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in virus load (VL)

  determined by IU per ml serum from baseline by \> 1.0 log10 step

  Up to day 6

Secondary Outcomes (16)

• Cmax (maximum measured concentration of the analyte in plasma)

  Up to 14 days after first drug administration

• tmax (time from dosing to maximum measured concentration of the analyte in plasma)

  Up to 14 days after first drug administration

• AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)

  Up to 14 days after first drug administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  Up to 14 days after first drug administration

• %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

  Up to 14 days after first drug administration

Study Arms (2)

BILB 1941 ZW

EXPERIMENTAL

Escalating Doses

Drug: BILB 1941 ZW

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BILB 1941 ZW DRUG

BILB 1941 ZW

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males from 18 - 65 years
• Written informed consent consistent with ICH (International Conference on Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any study procedures
• Chronic HCV infection demonstrated by positive HCV IgG Antibody
• HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
• Liver biopsy consistent with active Hepatitis C virus (HCV) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (Ishak or Metavir grade \<= 2)
• HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening
• Willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)

You may not qualify if:

• Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (IUD).
• Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
• Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
• Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
• Current alcohol or drug abuse, or history of the same, within the past twelve (12) months. All patients must abstain from alcohol from enrolment until completion of the study (visit 11).
• Any concurrent medical illness or disease requiring treatment or concomitant medications
• History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
• Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
• Patients treated with interferon and/or ribavirin within 6 months prior to screening
• Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
• Known hypersensitivity to drugs or excipients
• Patients with any one of the following laboratory values at screening:
• Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 2.5 x upper limit of normal (ULN) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
• Total bilirubin \> 1x ULN
• Alkaline phosphatase \> 1.5x ULN

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 2, 2014
• Study Start: July 1, 2004
• Primary Completion: April 1, 2006
• Last Updated: October 2, 2014

Record last verified: 2014-09