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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01525212




Registration number
NCT01525212
Ethics application status
Date submitted
31/01/2012
Date registered
2/02/2012
Date last updated
21/06/2013

Titles & IDs
Public title
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
Scientific 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
Secondary ID [1] 0 0
AI457-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-929075
Treatment: Drugs - BMS-929075
Treatment: Drugs - BMS-929075
Treatment: Drugs - BMS-929075
Treatment: Drugs - Placebo matching BMS-929075
Treatment: Drugs - Placebo matching BMS-929075

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

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

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

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


Treatment: Drugs: BMS-929075
Oral Suspension, = 25 mg, Once daily, 3 days

Treatment: Drugs: BMS-929075
Oral Suspension, = 100 mg, Once daily, 3 days

Treatment: Drugs: BMS-929075
Oral Suspension, = 400 mg, Once daily, 3 days

Treatment: Drugs: BMS-929075
Oral Suspension, (= 800 mg, Once daily) OR (= 400 mg, Twice daily), 3 days

Treatment: Drugs: Placebo matching BMS-929075
Oral Suspension, 0 mg, Once daily, 3 days

Treatment: Drugs: Placebo matching BMS-929075
Oral Suspension, 0 mg, (Once daily for = 800 mg group) OR (Twice daily for = 400 mg group), 3 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HCV RNA level on Day 4
Timepoint [1] 0 0
Within 4 days after the first dose
Secondary outcome [1] 0 0
Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28
Timepoint [1] 0 0
Days 1-28
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Days 1-28
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Days 1-28 (with SAE from screening to Day 30)
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time
Timepoint [10] 0 0
Day 3 (0h and 2h)
Secondary outcome [11] 0 0
Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
The relationship between antiviral activity and measures of exposure to BMS-929075
Timepoint [12] 0 0
Days 1-6

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2013
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Herston
Recruitment hospital [2] 0 0
Local Institution - Adelaide
Recruitment hospital [3] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01525212