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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01525212
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01525212