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Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

Primary Purpose

Chronic Hepatitis C

Status

Withdrawn

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

BMS-929075

Placebo matching BMS-929075

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women, ages 18 to 65 years, inclusive
Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy
HCV genotype 1a or 1b only
HCV RNA viral load of ≥ 100,000 IU/mL
Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis
Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive

Exclusion Criteria:

Any significant acute or chronic medical illness
History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
Any gastrointestinal surgery that could impact upon the absorption of study drug
Positive for hepatitis B surface antigen (HBsAg)
Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies
Smoking > 10 cigarettes per day
Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5x upper limit of normal (ULN)
Total Bilirubin ≥ 1.5x ULN
Hemoglobin < 10 g/dL
Platelets < 75,000 cell/μL
ALC (absolute lymphocyte count) < 1000 cell/μL
Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60 mL/min

Sites / Locations

Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075

Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075

Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075

Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075

Arm Description

Outcomes

Primary Outcome Measures

HCV RNA level on Day 4

Secondary Outcome Measures

Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28

Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28

Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time

Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time

Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time

Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time

Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time

Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time

Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time

The relationship between antiviral activity and measures of exposure to BMS-929075

Full Information

NCT ID

NCT01525212

First Posted

January 31, 2012

Last Updated

June 19, 2013

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01525212

Brief Title

Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

Official Title

Double-Blinded, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of BMS-929075 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Withdrawn

Study Start Date

April 2012 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075

Arm Type

Experimental

Arm Title

Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075

Arm Type

Experimental

Arm Title

Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075

Arm Type

Experimental

Arm Title

Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-929075

Intervention Description

Oral Suspension, ≤ 25 mg, Once daily, 3 days

Intervention Type

Drug

Intervention Name(s)

BMS-929075

Intervention Description

Oral Suspension, ≤ 100 mg, Once daily, 3 days

Intervention Type

Drug

Intervention Name(s)

BMS-929075

Intervention Description

Oral Suspension, ≤ 400 mg, Once daily, 3 days

Intervention Type

Drug

Intervention Name(s)

BMS-929075

Intervention Description

Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days

Intervention Type

Drug

Intervention Name(s)

Placebo matching BMS-929075

Intervention Description

Oral Suspension, 0 mg, Once daily, 3 days

Intervention Type

Drug

Intervention Name(s)

Placebo matching BMS-929075

Intervention Description

Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days

Primary Outcome Measure Information:

Title

HCV RNA level on Day 4

Time Frame

Within 4 days after the first dose

Secondary Outcome Measure Information:

Title

Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28

Time Frame

Days 1-28

Title

Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28

Time Frame

Days 1-28

Title

Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

Time Frame

Days 1-28 (with SAE from screening to Day 30)

Title

Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 3 (0h and 2h)

Title

Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time

Time Frame

Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)

Title

The relationship between antiviral activity and measures of exposure to BMS-929075

Time Frame

Days 1-6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women, ages 18 to 65 years, inclusive Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy HCV genotype 1a or 1b only HCV RNA viral load of ≥ 100,000 IU/mL Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive Exclusion Criteria: Any significant acute or chronic medical illness History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome Current or recent (within 3 months of study drug administration) gastrointestinal disease Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact upon the absorption of study drug Positive for hepatitis B surface antigen (HBsAg) Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies Smoking > 10 cigarettes per day Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5x upper limit of normal (ULN) Total Bilirubin ≥ 1.5x ULN Hemoglobin < 10 g/dL Platelets < 75,000 cell/μL ALC (absolute lymphocyte count) < 1000 cell/μL Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60 mL/min

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Local Institution

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Local Institution

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

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