Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001038987
Ethics application status
Not yet submitted
Date submitted
29/09/2011
Date registered
4/10/2011
Date last updated
4/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Placebo-Controlled, Single and Multiple Ascending Dose Study of BMS-929075 in Healthy Subjects.
Scientific title
Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-929075 in Healthy Subjects.
Secondary ID [1] 273129 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 270886 0
Condition category
Condition code
Infection 279059 279059 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PART A: Eight healthy subjects will be assigned to each of 6 sequential dose treatment groups; each receiving a single oral dose of either 5, 25, 100, 200, 400, a 'potential panel of less than or equal to 800mg' of BMS-929075 or placebo. The exact dose for the 'potential dose panel' will be based upon the safety and pharmacokinetic analysis from the previous dose panels.
Based on exposures from these subjects, the subjects given the 200mg dose (treatment group 4) and 400mg dose (treatment group 5) will remain in the clinic for further dosing.
Treatment Group 1: subjects receive a single oral dose of 5mg BMS-929075 or placebo.
Treatment Group 2: subjects receive a single oral dose of 25mg BMS-929075 or placebo.
Treatment Group 3: subjects receive a single oral dose of 100mg BMS-929075 or placebo.
Treatment Group 4: subjects receive a single oral dose of 200mg BMS-929075 or placebo, then a second 200mg oral dose of BMS-929075 or placebo with a high fat meal.
Treatment Group 5: subjects receive a single oral dose of 400mg BMS-929075 or placebo, then 100mg Ritonavir orally the night of Day 4 and a second 25mg oral dose of BMS-929075 or placebo with 100mg Ritonavir orally on Day 5.
Treatment Group 6: subjects receive a single oral dose of less than or equal to 800mg BMS-929075 or placebo.

PART B: Eight healthy subjects will be assigned to each of 6 sequential dose treatment groups; each receiving multiple oral doses of either 5, 25, 100, 200, 400, a 'potential panel of less than or equal to 800mg' of BMS-929075 or placebo. The exact dose for the 'potential dose panel' will be based upon the safety and pharmacokinetic analysis from the previous dose panels.
Treatment Group 1: subjects assigned to receive oral dose of 5mg BMS-929075 or placebo daily for 14 days.
Treatment Group 2: subjects assigned to receive oral dose of 25mg BMS-929075 or placebo daily for 14 days.
Treatment Group 3: subjects assigned to receive oral dose of 100mg BMS-929075 or placebo daily for 14 days.
Treatment Group 4: subjects assigned to receive oral dose of 200mg BMS-929075 or placebo daily for 14 days.
Treatment Group 5: subjects assigned to receive oral dose of 400mg BMS-929075 or placebo daily for 14 days.
Treatment Group 6: subjects assigned to receive oral dose of less than or equal to 800mg BMS-929075 or placebo daily for 14 days.
Intervention code [1] 269469 0
Treatment: Drugs
Intervention code [2] 269470 0
Prevention
Comparator / control treatment
Placebo oral suspension matching the active treatment
Control group
Placebo

Outcomes
Primary outcome [1] 279710 0
To assess the safety and tolerability of BMS-929075 following single and multiple oral doses in healthy subjects.
Timepoint [1] 279710 0
This will be assessed via safety laboratory testing performed at Screening and two days prior to treatment (Day -2), also PART A Day 4, 8 and 14 and PART B Day 4, 7, 10, 14, 17 and 28.
24hour urine collected the day prior to treatment (Day-1) also Day 1 PART A and Day 7 and 13 in PART B.
Vitals Signs at Screening and Day -1, Day 1, 2, 4, 6, 8 and 14 in PART A and Day 1, 7, 17 and 28 in PART B.
Secondary outcome [1] 294271 0
To assess the effect of single and multiple oral doses of BMS-929075 on ECG parameters.
Timepoint [1] 294271 0
ECG at Screening, Day -1, PART A Day 1 (serial at 0hr, 1hr, 2hr, 4hr and 6hr ), Day 2, 4, 8 and 14 and PART B Day 7, 14 (serial at 0hr, 1hr, 2hr, 4hr and 6hr), Day 15, 17 and 28 .
Secondary outcome [2] 294272 0
To assess the pharmacokinetics of BMS-929075 following single and multiple oral doses.
Timepoint [2] 294272 0
In PART A, PK samples will be taken predose Day 1 and at 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours post Day 1 dose, both predose and 12 hrs post on Day 2 and 6, and pre dose Day 3, 4, 7 and 8 (Day 5 to 8 applicable to treatment groups 4 and 5 only) .
In PART B, PK samples will be taken predose Day 1 and Day 14 and at 0.5hr, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours post Day 1 and Day 14, predose Day 2, 3, 4, 7, 10 and 16 and both predose and 12hrs post dose Day 15.
Secondary outcome [3] 294273 0
To assess the effect of single and multiple oral doses of BMS-929075 on blood pressure.
Timepoint [3] 294273 0
Serial Blood Pressure taken at 0hr, 1, 2, 4 and 6 hrs on Day -1, PART A Day 1 and PART B Day 14.
Secondary outcome [4] 294274 0
To assess the effects of Ritonavir on the single dose pharmacokinetics of BMS-929075.
Timepoint [4] 294274 0
Measured in PART A Treatment group 5 where subjects will undergo PK sampling at the same time points as in the other panels (Day 1 - 4) but will also have PK sampling on Day 5, 6, 7 and 8 with 100mg Ritonavir taken evening of Day 4 and morning of Day 5.
Secondary outcome [5] 294275 0
To assess the effects of a high fat meal on the single dose pharmacokinetics of BMS-929075.
Timepoint [5] 294275 0
Measured in PART A Treatment group 4 where subjects will undergo PK sampling at the same time points as in the other panels (Day 1 - 4) but will also have PK sampling on Day 5, 6, 7, and 8 after a second 200mg dose of BMS-929075 with a high fat meal on Day 5.

Eligibility
Key inclusion criteria
Healthy men and women ages 18 to 49
Body Mass Index (BMI) of 18 to 32kg/m2
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any significant acute or chronic medical illness, including any:
- liver disease with laboratory screening results for ALT, AST or bilirubin > upper limit of normal
- gastrointestinal disease within the past 3 months.
Any major surgery, donation of blood or plasma to a blood bank or receipt of a blood transfusion within the past 4 weeks.
Smoking more than 10 cigarettes per day.
Healthy subjects with any of the following ECG findings prior to dosing:
- PR>/= 210 msec
- QRS>/= 120 msec
- QT>/= 500 msec
- QTcF>/+ 450 msec
Positive urine screen for drugs of abuse or positive screen for Hepatitis C, Hepatitis B or HIV.

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)
Each study participant deemed eligible for the study will be assigned a sequential study number by the study staff. The pharmacist will then assign treatment to each subject number according to a computer generated randomisation schedule. The pharmacist is the only person with access to this schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised Controlled Trial: participants are assigned to intervention groups by chance. The randomisation schedule is computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269951 0
Commercial sector/Industry
Name [1] 269951 0
Bristol-Myers Squibb Company
Country [1] 269951 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Company
Address
P.O. Box 4000
Princeton, NJ 08543-4000
Country
United States of America
Secondary sponsor category [1] 268948 0
None
Name [1] 268948 0
Address [1] 268948 0
Country [1] 268948 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271920 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 271920 0
The Alfred Hospital
85 Commercial Road
Prahran VIC 3004
Melbourne
Ethics committee country [1] 271920 0
Australia
Date submitted for ethics approval [1] 271920 0
26/09/2011
Approval date [1] 271920 0
Ethics approval number [1] 271920 0

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-929075 in healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33213 0
Address 33213 0
Country 33213 0
Phone 33213 0
Fax 33213 0
Email 33213 0
Contact person for public queries
Name 16460 0
Sarah Wilson
Address 16460 0
Nucleus Network
Level 5, 89 Commercial Road
Prahran VIC 3004
Melbourne
Country 16460 0
Australia
Phone 16460 0
+61 3 9076 8932
Fax 16460 0
+61 3 9076 8940
Email 16460 0
s.wilson@nucleusnetwork.com.au
Contact person for scientific queries
Name 7388 0
A/Prof Peter Hodsman
Address 7388 0
Nucleus Network
Level 5, 89 Commercial Road
Prahran VIC 3004
Melbourne
Country 7388 0
Australia
Phone 7388 0
+61 3 9076 8960
Fax 7388 0
+61 3 9076 8911
Email 7388 0
p.hodsman@nucleusnetwork.com.au

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

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