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Trial registered on ANZCTR


Registration number
ACTRN12612000657820
Ethics application status
Approved
Date submitted
12/06/2012
Date registered
19/06/2012
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An absolute bioavailability, safety and tolerability study of BMS-936557 following subcutaneous administration compared to intravenous administration in healthy subjects.
Scientific title
An absolute bioavailability, safety and tolerability study of BMS-936557 following subcutaneous administration compared to intravenous administration in healthy subjects.
Secondary ID [1] 280653 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bioequivalence assessment between 2 administrations of BMS-936557 286676 0
Condition category
Condition code
Other 286979 286979 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
22 Healthy subjects will be assigned to one of the below treatment arms -

Treatment A (N=6): Open-label intravenous (IV), 90 mg/mL x 2.4 mL (total 216 mg/ 50 mL normal saline).

Treatment B (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/mL x 2 injections (1.2 mL per injection / total 216 mg per subject) or placebo administered at one location, 2 adjunct injections in one anterior upper thigh.

Treatment C (N=8): Double-blind (6 active : 2 placebo) subcutaneous (SC), 90 mg/mL x 4 injections (1.2 mL per injection / total 432 mg per subject) or placebo administered at 2 locations, 2 adjunct injections in each anterior upper thigh.

Subjects will be randomized to Treatment A (active),
Treatment B (active), Treatment B (placebo), Treatment C (active) or Treatment C (placebo) in a ratio of 3:3:1:3:1. Randomizations will be stratified within each group equally to either the 60- < 80 kg weight group or the 80-100 kg weight group .
Intervention code [1] 285060 0
Treatment: Drugs
Comparator / control treatment
Placebo matching the SC treatment arm B
Control group
Placebo

Outcomes
Primary outcome [1] 287311 0
The absolute bioavailability of BMS-936557 following 216 mg and 432 mg SC administration compared to IV administration in healthy subjects.
Timepoint [1] 287311 0
The absolute bioavailability of BMS-936557 following 216 mg and 432 mg SC administration compared to IV administration will be estimated as a ratio of dosed
normalized exposure following SC dose over that following IV dosing.

Treatment A (IV) - PK sampling will be performed on day 1 (pre-dose, 20 mins, 1 hr, 2 hrs, 6hrs and 12hrs post dose), day 2 , day 3, day 4, day 6, day 8, day 15, day 29, day 43 and day 57 post dose.

Treatment arm B and C (SC) - PK sampling will be performed on day 1 (pre dose and 12 hours post dose) day 2 (24 & 36 hrs post dose), day 3 (48 & 60hrs post dose), day 4, day 5, day 6, day 8, day 15, day 29, day 43 and day 57.
Secondary outcome [1] 297881 0
Pharmacokinetics will be assessed by single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), dose-normalized (DN) AUC(0-T), AUC(INF), DN AUC(INF), T-HALF, CLT (IV only), CLT/F (SC only), Vz (IV only), Vss (IV only), and Vz/F (SC only).
Timepoint [1] 297881 0
Treatment A (IV) - PK sampling will be performed on day 1 (pre-dose, 20 mins, 1 hr, 2 hrs, 6hrs and 12hrs post dose), day 2 , day 3, day 4, day 6, day 8, day 15, day 29, day 43 and day 57 post dose.

Treatment arm B and C (SC) - PK sampling will be performed on day 1 (pre dose and 12 hours post dose) day 2 (24 & 36 hrs post dose), day 3 (48 & 60hrs post dose), day 4, day 5, day 6, day 8, day 15, day 29, day 43 and day 57.
Secondary outcome [2] 297882 0
Safety Outcome Measures. The following Adverse events have been reported - infections (such as skin infections, abcesses, diverticulitis) and allergic reactions to study drug. Other common side effects are -
-Cough
-Pharyngolaryngeal pain (throat pain)
-Back pain
-Dizziness
-Pyrexia/hyperthermia (fever)
-Rash
Timepoint [2] 297882 0
Safety assessments will be based on the following -
- medical review of adverse event reports (screening, day-1, day 1 - 6, day 8, 15, 29, 43 and 57).
-vital sign measurements (screening, day-1, day 1, 2, 8, 15, 29, 43 and 57)
- ECGs (screening, day 1, 3, 5, and 8).
-physical examinations (screening, day-1, day 8, 29 and 57).
-clinical laboratory tests (screening, day-1, day 2, 5, 29, 43 and 57).
The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance.
Secondary outcome [3] 297883 0
Immunogenicity Measures
Timepoint [3] 297883 0
Blood samples will be collected on Days 1, 15, 29, 43, and 57 for assessment of BMS-936557 antibodies
Secondary outcome [4] 297884 0
Biomarker Measures:
Timepoint [4] 297884 0
Blood samples will be collected on Days 1, 2, 3, 8 and 57 for assessment of BMS-936557 antibodies.

Eligibility
Key inclusion criteria
Healthy male and female subjects, ages 18-55 years inclusive, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations, will be eligible to participate in the study. All subjects must weigh between 60-100 kg, inclusive. Subjects within each treatment group will be weight matched between the 60 - < 80 kg and the 80 - 100 kg weight groups. All subjects must have a negative QuantiFERON-TB Gold test (QFT-G) at screening
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active TB requiring treatment within the previous 3 years.

Any significant acute or chronic medical illness, including any:
-bacterial infections within previous 12 weeks
-HIV, Hep B or Hep C
- gastrointestinal disease within the past 3 months
-autoimmuine disorders
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
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2012
Actual
8/08/2012
Date of last participant enrolment
Anticipated
Actual
13/08/2012
Date of last data collection
Anticipated
Actual
18/10/2012
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285424 0
Commercial sector/Industry
Name [1] 285424 0
Bristol-Myers Squibb
Country [1] 285424 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
P.O. Box 4000
Princeton, NJ 08543-4000
Country
United States of America
Secondary sponsor category [1] 284276 0
None
Name [1] 284276 0
Address [1] 284276 0
Country [1] 284276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287447 0
Alfred Hospital HREC
Ethics committee address [1] 287447 0
Ethics committee country [1] 287447 0
Australia
Date submitted for ethics approval [1] 287447 0
25/06/2012
Approval date [1] 287447 0
01/08/2012
Ethics approval number [1] 287447 0

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

Contacts
Principal investigator
Name 34298 0
Dr Jason Licliter
Address 34298 0
Nucleus network
Burnet Tower, 5th Floor
89 Commercial Road
Prahran, 3004, VIC
Country 34298 0
Australia
Phone 34298 0
+61390768960
Fax 34298 0
Email 34298 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 17545 0
Sue Mason
Address 17545 0
Nucleus Network
Level 5, 89 Commercial Road
Prahran VIC 3004
Melbourne
Country 17545 0
Australia
Phone 17545 0
+61 3 9076 9017
Fax 17545 0
+61 3 9076 8940
Email 17545 0
s.mason@nucleusnetwork.com.au
Contact person for scientific queries
Name 8473 0
A/Prof Peter Hodsman
Address 8473 0
Nucleus Network
Level 5, 89 Commercial Road
Prahran VIC 3004
Melbourne
Country 8473 0
Australia
Phone 8473 0
+61 3 9076 8960
Fax 8473 0
+61 3 9076 8911
Email 8473 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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