Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001152819
Ethics application status
Not yet submitted
Date submitted
11/09/2012
Date registered
31/10/2012
Date last updated
31/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label, 2-Part, Single Dose, Randomized Study to Evaluate the Pharmacokinetics of combination etoricoxib/tizanidine tablets in Healthy Adult Subjects
Scientific title
An Open-Label, 2-Part, Single Dose, Randomized Study to Evaluate the Pharmacokinetics of a Probe Formulation of MK-0663B (etoricoxib/tizanidine MR) in Healthy Adult Subjects.
Secondary ID [1] 281234 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pain in Musculoskeletal disorders 287400 0
Condition category
Condition code
Musculoskeletal 287731 287731 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PART 1

Three fixed dose combination formulation prototypes will be compared to co-administration of the marketed formulations. The difference between the 3 prototypes for part 1 are different rates of dissolution.

Treatment A: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 1)

Treatment B: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 2)

Treatment C: Administration of a single oral dose of MK-0663B 90 mg etoricoxib /6 mg tizanidine MR (Prototype 3)

Treatment D: Co-administration of a single oral dose of etoricoxib 90 mg & tizanidine MR 6 mg
All participants will receive single oral doses of each treatment in a 4 way crossover fashion with a minimum of 7 day washout period in between.

PART 2
The prototype most closely approximating co-administration of etoricoxib 90 mg & tizanidine MR 6 mg will be selected for Part 2.


Treatment E: Administration of a single oral dose of MK-0663B (Prototype selected from Part 1)

Treatment F: Co-administration of a single oral dose of etoricoxib 90 mg & tizanidine MR 6 mg

All participants will receive single oral doses of each treatment in a 2 way crossover fashion with a minimum of 7 day washout period in between.
MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Intervention code [1] 285678 0
Treatment: Drugs
Comparator / control treatment
Part 1
4 Way Crossover

Part 2
2 way crossover
Control group
Active

Outcomes
Primary outcome [1] 287971 0
Compare the pharmacokinetic profile of three single-dose formulations of MK-0663B (90 mg etoricoxib /6 mg tizanidine MR), a tablet administered as a single bi-layer tablet with the co-administration of etoricoxib 90 mg and tizanidine MR 6 mg by means of AUC0-last, Cmax, tmax, and t1/2 under fasting and non-fasting conditions.

Measured by: pharmacokinetics of etoricoxib and tizanidine
Timepoint [1] 287971 0
Blood samples for determining etoricoxib and tizanidine in plasma will be collected over a period of 72 hours post-dose
(All Arms in both Parts 1 & 2): predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 72hr post dose (2 samples collected at each time point)
Secondary outcome [1] 299162 0
To monitor the safety of subjects participating in the study and tolerability of the MK-0663B probe formulation in comparison with the co-administration of etoricoxib 90 mg and tizanidine MR 6 mg considering adverse events, physical exams, vital sign measurements, 12-lead electrocardiograms, and laboratory safety tests (serum chemistry, hematology and urinalysis).

Measured by adverse events, physical exams, vital sign measurements, 12-lead electrocardiograms, and laboratory safety tests (serum chemistry, haematology and urinalysis)
Timepoint [1] 299162 0
Adverse events: from screening (enrollment into study) through to study completion (14 days post dose)

Physical Exams: screening (enrollment into study), pre dose (visit 1), and 14 days post dose
Vital Signs Measurement: screening (enrollment into study), pre dose (visit 1), 4hr, 8hr, 14 days post dose
ECG: screening (enrollment into study), pre dose (visit 1), , 14 days post dose
Lab safety tests: screening (enrollment into study), pre dose (visit 1), , 14 days post dose

Eligibility
Key inclusion criteria
-BMI < 30kg/m2
-Female of reproductive potential to have negative pregnancy test and agree to use double-barrier contraception
-Good health based on medical history, physical examination, vital sign measurements, ECG and laboratory assessments
-Non smoker
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-History of emotional problems or clinically significant psychiatric disorder within 5yrs
-Clinically significant disease/disorder of any body systems
-Creatinine clearance of <80mL/min
-History of neoplastic disease
-Breast feeding mother
-History of stroke, chronic seizures or major neurological disorder
-Current use of prescription/non-prescription medication (includes oral contraception)-Consumes excessive amounts of alcohol
-Consumes excessive amounts of caffeine
-History of significant or severe allergies or anaphylactic reaction
-History of serious adverse experiences related to non-steroidal anti-inflammatory drug
-Regular user of illicit drugs

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285988 0
Commercial sector/Industry
Name [1] 285988 0
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Country [1] 285988 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address
One Merck Drive
Whitehouse Station, NJ, 08889-010
Country
United States of America
Secondary sponsor category [1] 284808 0
None
Name [1] 284808 0
Address [1] 284808 0
Country [1] 284808 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288037 0
Ethics committee address [1] 288037 0
Ethics committee country [1] 288037 0
Date submitted for ethics approval [1] 288037 0
05/09/2012
Approval date [1] 288037 0
Ethics approval number [1] 288037 0

Summary
Brief summary
An open-label, 2-part, randomized, single-dose, crossover study to initially characterize the pharmacokinetics, safety, and tolerability of MK-0663B 90 mg/6 mg
formulated as prototype tablets under fasted and fed conditions when compared to coadministration of the individual components. The change in pharmacokinetics for etoricoxib and tizanidine when administered under fasting (Part 1) and fed conditions (Part 2) will be characterized.

MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34700 0
Address 34700 0
Country 34700 0
Phone 34700 0
Fax 34700 0
Email 34700 0
Contact person for public queries
Name 17947 0
A/Prof Peter Hodsman
Address 17947 0
5th Floor Burnet Tower
89 Commercial Road
Melbourne Victoria 3004
Country 17947 0
Australia
Phone 17947 0
+61 3 90768900
Fax 17947 0
Email 17947 0
contactus@nucleusnetwork.com.au
Contact person for scientific queries
Name 8875 0
A/Prof Peter Hodsman
Address 8875 0
5th Floor Burnet Tower
89 Commercial Road
Melbourne Victoria 3004
Country 8875 0
Australia
Phone 8875 0
+61 3 90768900
Fax 8875 0
Email 8875 0
contactus@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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