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Trial registered on ANZCTR
Registration number
ACTRN12612000375853
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
2/04/2012
Date last updated
6/06/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
A Single Dose Clinical Trial to Study the Safety, Tolerability, and Pharmacokinetics of Intravenous MK-8226 in Healthy Subjects
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Scientific title
A Single Dose Clinical Trial to Study the Safety, Tolerability, and Pharmacokinetics of Intravenous MK-8226 in Healthy Subjects
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Secondary ID [1]
280217
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Inflammatory and Immune System
286350
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0
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Other inflammatory or immune system disorders
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Skin
286406
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0
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Panel A: MK-8226 0.1 mg/kg single IV dose
Panel B: MK-8226 0.3 mg/kg single IV dose
Panel C: MK-8226 1 mg/kg single IV dose
Panel D: MK-8226 3 mg/kg single IV dose
Panel E: MK-8226 10 mg/kg single IV dose
In each of the panels above, participants will be randomised to receive either the dose level described for the specific panel or placebo. MK8226 is being developed for treatment of patients with moderate to severe atopic dermatitis. However, this study is in healthy volunteers only.
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Intervention code [1]
284546
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Treatment: Drugs
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Comparator / control treatment
Placebo controlled. Normal saline, single IV dose to be used as placebo.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Proportion of subjects experiencing at least one adverse event, as determined by the investigator via continuous monitoring of study participants and by repeated clinical and laboratory measures including ECG, Vital Signs and laboratory blood tests.
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Assessment method [1]
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Timepoint [1]
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Time Frame: continuously monitored up to 98 days post treatment
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Primary outcome [2]
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Proportion of subjects with clinically significant ECG and vital signs abnormalities
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Assessment method [2]
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Timepoint [2]
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Time Frame:
ECG: 24 hrs post treatment (Day 2), Days 7, 14, 21, 56, 84 and 98.
Vitals Signs:2, 3, 6, 12 hrs post treatment (Day 1); 24, and 48 hrs post treatment (Days 2 and 3); Days 7, 14, 21, 42, 56, 70, 84 and 98.
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Primary outcome [3]
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Proportion of subjects with clinically significant laboratory abnormalities from hematology, chemistry, and urinalysis tests.
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Assessment method [3]
286815
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Timepoint [3]
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Time Frame: 24 hrs post treatment (Day 2), Days 7, 14, 21, 84 and 98.
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Secondary outcome [1]
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Pharmacokinetic data following administration of MK-8226: area under the curve (AUC[0-infinity]) (AUC[0-last]) from blood (serum) analysis
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Assessment method [1]
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Timepoint [1]
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Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98
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Secondary outcome [2]
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Pharmacokinetic data following administration of MK-8226: maximum concentration (Cmax) from blood (serum) analysis.
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Assessment method [2]
296719
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Timepoint [2]
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Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
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Secondary outcome [3]
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Pharmacokinetic data following administration of MK-8226: clearance (CL) from blood (serum) analysis.
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Assessment method [3]
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Timepoint [3]
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Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
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Secondary outcome [4]
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Pharmacokinetic data following administration of MK-8226: volume of distribution (Vd) from blood (serum) analysis.
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Assessment method [4]
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Timepoint [4]
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Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
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Secondary outcome [5]
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Pharmacokinetic data following administration of MK-8226: apparent terminal half-life (t1/2) from blood (serum) analysis.
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Assessment method [5]
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Timepoint [5]
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Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
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Eligibility
Key inclusion criteria
-Subject judged to be in good health based on medical history, physical examination, ECG, vital sign measurements and laboratory safety tests
-Non-smoker
-BMI <30kg/m2
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
-Mentally or legally incapacitated or having significant emotional problems or has a history of clinically significant psychiatric disorder
-History of any clinically significant diseases/disorders
-Creatinine Clearance <80mL/min
-History of neoplastic disease
-Pregnant, breast feeding or expecting to conceive
-Major surgery or blood donation within 4 weeks
-Consumes excessive amounts of alcohol or caffeine
-History of significant allergies
-Regular/recreational drug user
-Participated in another clinical study within 4 weeks
-Positive to Hepatitis B, C or HIV
-Recent history of serious infection/infection requiring systemic antibiotics
-Received a live virus vaccine within 4 weeks.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/04/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
42
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
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Address [1]
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One Merck Drive
Whitehouse Station, NJ 08889-0100
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
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Address
One Merck Drive
Whitehouse Station, NJ 08889-0100
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
283836
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Country [1]
283836
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Alfred Ethics Committee
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Ethics committee address [1]
286974
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Ethics committee country [1]
286974
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Date submitted for ethics approval [1]
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29/02/2012
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Approval date [1]
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23/04/2012
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Ethics approval number [1]
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77/12
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Summary
Brief summary
A study to evaluate the safety, tolerability and metabolism of MK8226 in healthy volunteers. MK8226 is being developed for treatment of patients with moderate to severe atopic dermatitis. However, this study is in healthy volunteers only.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jason Lickliter
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Address
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Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+613 9076 8960
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sue Mason
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Address
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Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+613 9076 9017
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Fax
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+613 9076 8911
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jason Lickliter
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Address
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Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
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Country
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Australia
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Phone
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+613 9076 8960
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Fax
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+613 9076 8911
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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