Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000788279
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
10/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Ascending single and multiple oral doses of chemokine receptor 1 antagonist administered to healthy subjects
Scientific title
A Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-817399 in Healthy Subjects
Secondary ID [1] 252622 0
IM126-001
Universal Trial Number (UTN)
Trial acronym
IM126001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 243498 0
Condition category
Condition code
Inflammatory and Immune System 239773 239773 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascending single and multiple oral doses of BMS-817399, a chemokine receptor 1 antagonist administered to healthy subjects.
The effect of food (high-fat meal) will also be studied.

In the single ascending dose part (SAD; Part A), 8 subjects/panel, will receive single oral dose of the test medication (or placebo in 3:1 ratio) in a double blinded manner as follows:
Panel 1: 20 mg capsule
Panel 2: 80 mg capsule
Panel 3: 200 mg capsule under fast in Period 1 and 200 mg capsule after a high fat meal* in Period 2 (to study food effect)
Panel 4: 400 mg capsule in Period 1 and 400 mg oral suspension in Period 2
Panel 5: 800 mg capsule
Panel 6: 1600 mg oral suspension
Panel 7: 2000 mg oral suspension.
*High fat meal contain 54.6 mg fat, 82.3 mg carbohydrate and 32.1 gram of protein. The high fat meal will be served within 30 minutes prior to dosing and the subject must ingest the meal completely within this time period.

The duration of each period in Part A is 5 days postdose, with a single dose administered on Day 1.

No subject from Part A of the study will participate in Part B of the study.

In the multiple ascending dose part (MAD; Part B), 8 subjects/panel, will receive the test medication (or placebo in 3:1 ratio) orally 2 times a day (every 12 hours) for 13 days and a single dose on Day 14 in a double blinded manner as follows:
Panel 1: 40 mg capsule
Panel 2: 100 mg capsule
Panel 3: 200 mg capsule
Panel 4: 400 mg capsule
Panel 5: 800 mg capsule
Panel 6: 1000 mg capsule

The duration of each panel in Part B will be 17 days with dosing up to Day 14.
Intervention code [1] 237091 0
Treatment: Drugs
Comparator / control treatment
The placebo capsule is an opaque, gray, size #00 two-piece, hard gelatin capsule that contains Microcrystalline Cellulose, NF (99.75% w/w) and Magnesium Stearate, NF (0.25% w/w).

Placebo for the Oral suspension is microcrystalline cellulose in 0.25% w/v hydroxypropyl methylcellulose in water.

Of the 8 subjects in each dose panel in the whole study, 6 subjects will be randomized to receive the active compound (BMS-817399) and 2 subjects to receive placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 240539 0
Safety & tolerability assessment of BMS-817399 will be based on medical review of adverse event reports, the results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance.
Timepoint [1] 240539 0
The subjects will be monitored for any adverse events continuously while they remain in the clinic. Additionally, site staff will ask the subjects for any adverse events that they may be undergoing.

In Part A of the study, subjects will stay at the study site for a total of 6 nights per period. Subjects in Panels 3 and 4 will spend a total of 11 and 12 nights respectively, to complete Period 2.

Subjects in Part B will spend a total of 18 nights at the study site.
Secondary outcome [1] 257112 0
To assess the effects of BMS-817399 on the QTc (QT interval corrected for heart rate) and PR intervals, electrocardiograms (ECGs) will be measured at predetermined timepoints throughout the study.
Timepoint [1] 257112 0
In Part A (SAD) of the study, ECGs will be measured at the following timepoints:
Baseline, and on Days 1, 2, & 5

In Part B (MAD) of the study, ECGs will be measured at the following timepoints:
Baseline, and on Days 1, 2, 3, 5, 7, 9, 11, 14, 15 & 17.

Eligibility
Key inclusion criteria
Healthy subjects (men and women) having Body Mass Index (BMI) between 18 and 32 kg/m2
Women must not be of childbearing potential (i.e., who are postmenopausal or surgically sterile).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any significant acute or chronic medical illness.
Subjects at risk for tuberculosis (TB).
Evidence of organ dysfunction or any clinically significant deviation from normal.
Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) greater than 1.25 x upper normal limit (UNL) at screening.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237485 0
Commercial sector/Industry
Name [1] 237485 0
Bristol-Myers Squibb
Country [1] 237485 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Route 206 & Province Line Road
Princeton, NJ 08543
Country
United States of America
Secondary sponsor category [1] 236968 0
None
Name [1] 236968 0
Address [1] 236968 0
Country [1] 236968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239606 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 239606 0
Alfred Hospital
Commercial Road
Melbourne Vic. 3004
Ethics committee country [1] 239606 0
Australia
Date submitted for ethics approval [1] 239606 0
27/07/2009
Approval date [1] 239606 0
27/08/2009
Ethics approval number [1] 239606 0

Summary
Brief summary
Nucleus Network Limited.
The primary purpose of this study is to determine if BMS-817399 can be safely administered to human beings at dose ranges that may provide clinical benefit to patients of rheumatoid arthritis. The study has no formal research hypothesis to be statistically tested. The study will be carried out in normal healthy volunteers under close observation to determine BMS-817399 dose ranges that are safe and tolerable in human beings. Initially, BMS-817399 will be given as a single dose by mouth, with doses increasing till the highest tolerated dose that is also safe is determined. Following this, BMS-817399 will be given as more than one dose daily by mouth for a period of fourteen days, with doses increasing in amount till the highest tolerated dose that is also safe is determined. To know the amount of BMS-817399 that has entered into the body, blood will be drawn for testing. Other test will also be done to see if BMS-817399 is safe and has the expected effects in the body. During the period of dosing and testing, the patient will be confined to the clinic for close observation. Taking part in this study will not provide any medical benefit to the subjects.
Trial website
www.nucleusnetwork.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30019 0
Address 30019 0
Country 30019 0
Phone 30019 0
Fax 30019 0
Email 30019 0
Contact person for public queries
Name 13266 0
Mary Franich
Address 13266 0
Centre for Clinical Studies
Level 5 Burnet Institute - Alfred Medical Research & Education Precinct (AMREP)
89 Commercial Road
Melbourne Vic 3004
Country 13266 0
Australia
Phone 13266 0
1800 243 733
Fax 13266 0
61.3.8562.1393
Email 13266 0
[email protected]
Contact person for scientific queries
Name 4194 0
Paulo Maciag, MD, PhD
Address 4194 0
Bristol-Myers Squibb
Route 206 & Province Line Road
LVL/E.1307
Princeton, NJ 08543
Country 4194 0
United States of America
Phone 4194 0
+1 609 252 6345
Fax 4194 0
+1 609 252 7035
Email 4194 0
[email protected]

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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