Multiple Oral Doses of BI 207127 NA in Treatment naïve and Treatment-experienced Hepatitis C Virus (HCV)-Infected Patients

NCT02176525 | Completed Phase 1 Results

• 1 other identifier: 1241.2
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Virologic Response (VR)

  Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.

  Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5

Secondary Outcomes (22)

• Time Dependent Change From Baseline in Viral Load (VL)

  Baseline, up to day 7

• Cmax

  5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

• Cmin

  5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

• Tmax

  5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

• AUC0-τ

  5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1

Study Arms (3)

BI 207127 in patients with cirrhosis

EXPERIMENTAL

multiple rising doses

Drug: BI 207127 NA

BI 207127 in patients without cirrhosis

EXPERIMENTAL

multiple rising doses

Drug: BI 207127 NA

Placebo in patients without cirrhosis

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 207127 NA DRUG

BI 207127 in patients with cirrhosis; BI 207127 in patients without cirrhosis

Placebo DRUG

Placebo in patients without cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults from 18 - 70 years
• Male OR female with documented hysterectomy OR menopausal female with last menstrual period at least 12 months prior to screening
• Written informed consent consistent with International Conference on Harmonization/Good Clinical Practice and local legislation given prior to any study procedures
• Chronic HCV infection demonstrated by positive HCV immunoglobulin G Antibody
• HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
• For non-cirrhotic cohorts: Liver biopsy obtained within the last 36 months consistent with HCV infection showing minimal to mild liver fibrosis and without cirrhosis (Ishak or Metavir grade ≤ 2). For cirrhotic cohorts, previous liver biopsy or Fibroscan consistent with liver cirrhosis performed at any time before screening
• HCV RNA load \> 100,000 IU RNA per ml serum at screening

You may not qualify if:

• All fertile males not willing to use 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)
• Patients who have been treated with at least one dose of any HCV-polymerase inhibitor for acute or chronic hepatitis C infection
• Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
• Decompensated liver disease within past 12 months, as indicated by variceal bleeding, ascites, encephalopathy, Prothrombin or International Normalized Ratio (INR) prolonged to \>1.7 x upper limit of normal (ULN), serum bilirubin \> 2 mg/dl or albumin \< 3.5 g/dl (i.e. Child-Pugh grade B, score \> 7)
• For non-cirrhotic cohorts: Any previous liver biopsy consistent with cirrhosis. For cirrhotic cohorts: Any liver biopsy or fibroscan result from last 2 years excluding liver cirrhosis.
• Positive test for human immunodeficiency virus (HIV) or hepatitis B antigen at screening
• Clinically significant abnormalities at screening ECG, including but not limited to a QTc longer than 435 msec, Pulse Rate \> 240 msec at baseline and any bundle branch block pattern, but not necessarily non-specific T wave abnormalities
• History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
• Patients treated with any interferon (IFN) (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
• Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination from 7 days before treatment and during treatment
• 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
• Known hypersensitivity to drugs or excipients
• Patients with any one of the following laboratory values at screening:
• Alanine transaminase (ALT) \> 3x ULN, local lab
• Aspartate aminotransferase (AST) \> 3x ULN, local lab

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

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 26, 2014
• First Posted: June 27, 2014
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-04