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Trial registered on ANZCTR


Trial ID
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
Scientific title
A Single Dose Clinical Trial to Study the Safety, Tolerability, and Pharmacokinetics of Intravenous MK-8226 in Healthy Subjects
Secondary ID [1] 280217 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 286154 0
Condition category
Condition code
Inflammatory and Immune System 286350 286350 0 0
Other inflammatory or immune system disorders
Skin 286406 286406 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284546 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled. Normal saline, single IV dose to be used as placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 286813 0
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.
Timepoint [1] 286813 0
Time Frame: continuously monitored up to 98 days post treatment
Primary outcome [2] 286814 0
Proportion of subjects with clinically significant ECG and vital signs abnormalities
Timepoint [2] 286814 0
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.
Primary outcome [3] 286815 0
Proportion of subjects with clinically significant laboratory abnormalities from hematology, chemistry, and urinalysis tests.
Timepoint [3] 286815 0
Time Frame: 24 hrs post treatment (Day 2), Days 7, 14, 21, 84 and 98.
Secondary outcome [1] 296718 0
Pharmacokinetic data following administration of MK-8226: area under the curve (AUC[0-infinity]) (AUC[0-last]) from blood (serum) analysis
Timepoint [1] 296718 0
Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98
Secondary outcome [2] 296719 0
Pharmacokinetic data following administration of MK-8226: maximum concentration (Cmax) from blood (serum) analysis.
Timepoint [2] 296719 0
Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
Secondary outcome [3] 296720 0
Pharmacokinetic data following administration of MK-8226: clearance (CL) from blood (serum) analysis.
Timepoint [3] 296720 0
Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
Secondary outcome [4] 296721 0
Pharmacokinetic data following administration of MK-8226: volume of distribution (Vd) from blood (serum) analysis.
Timepoint [4] 296721 0
Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.
Secondary outcome [5] 296722 0
Pharmacokinetic data following administration of MK-8226: apparent terminal half-life (t1/2) from blood (serum) analysis.
Timepoint [5] 296722 0
Time Frame: at end of infusion (treatment), 6, 12, 24, 48 hrs post treatment; Days 7, 14, 21, 42, 56, 70, 84, and 98.

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
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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

Funding & Sponsors
Funding source category [1] 284969 0
Commercial sector/Industry
Name [1] 284969 0
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address [1] 284969 0
One Merck Drive
Whitehouse Station, NJ 08889-0100
Country [1] 284969 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 08889-0100
Country
United States of America
Secondary sponsor category [1] 283836 0
None
Name [1] 283836 0
Address [1] 283836 0
Country [1] 283836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286974 0
The Alfred Ethics Committee
Ethics committee address [1] 286974 0
Ethics committee country [1] 286974 0
Date submitted for ethics approval [1] 286974 0
29/02/2012
Approval date [1] 286974 0
23/04/2012
Ethics approval number [1] 286974 0
77/12

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33976 0
Dr Jason Lickliter
Address 33976 0
Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
Country 33976 0
Australia
Phone 33976 0
+613 9076 8960
Fax 33976 0
Email 33976 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 17223 0
Ms Sue Mason
Address 17223 0
Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
Country 17223 0
Australia
Phone 17223 0
+613 9076 9017
Fax 17223 0
+613 9076 8911
Email 17223 0
s.mason@nucleusnetwork.com.au
Contact person for scientific queries
Name 8151 0
Dr Jason Lickliter
Address 8151 0
Nucleus Network 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne VIC 3004
Country 8151 0
Australia
Phone 8151 0
+613 9076 8960
Fax 8151 0
+613 9076 8911
Email 8151 0
j.lickliter@nucleusnetwork.com.au