27 April 2010 Jane Fendl
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Transcript of 27 April 2010 Jane Fendl
Version: Final 14-Apr-2010 1
27 April 2010
Jane Fendl
MODULE G A Comparative Trial between Sun Rise Gum and Sun Set
Gum in Healthy Gum Chewing Subjects
NOTE: this presentation is just for demonstration & may not be consistent or accurate.
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AGENDAPart IStudy TeamTrial TimelinesOverview of Protocol Review
Trial ProductsInclusion / Exclusion CriteriaVisit ProceduresAEs, SAEs,
Questions
Part IIInvestigational drugMonitoringQuestions
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STUDY TEAM Clinician
Associate Director
Project Manager
Data Manager
Statistician
Primary Clinical Research Associate
Project Associate
Dr. Doublemint
Dr. Juicey Fruit
Jane Fendl
Dr. Jot It Down
Dr. Clinical Significance
John “Omissions” Doe
Jenny “Organized” Jones
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TIMELINES
Screening: 14 Apr 2010 – 30 Apr 2010
FPFV: 01 May 2010
FPFT to LPLT: 12 weeks
LPLV: 24 Jul 2010
DBL: 08 Sep 2010
Clinical Trial Report: 07 Nov 2010
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OVERVIEW OF CHEWING GUM
Sun Rise is the new formulation of the ultra long lasting gum
Sun Set is the current formulation of the ultra long lasting gum
Sun Rise◦ offers longer lasting flavor ◦ has predictable steady flavor profile that is
expected to result in a reduced rate of buying
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BACKGROUND
As of today: 10 clinical trials have been conducted for Sun Rise and
Sun Set gum Includes 9 Phase 1 trials and 2 Phase 2 exploratory
trials 1000 subjects have chewed Sun Rise or Sun Set gum Data from Previous trials have shown
In single chew studies, peak flavor concentrations were observed at ~10 hours post initial chew
Elimination half-life (t½) of approximately 20 hours Generally well enjoyed (most frequently reported AEs
in the trials were headache, a common side effect in prolonged chewing and hunger )
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RATIONALEThe Sun Rise formulation will be compared to the
Sun Set formulation. Both have identical formulations but the ingredients are from different campaigns as the manufacturing process has been optimized.
The current trial will test for taste equivalence between the two formulations Sun Rise (SR) and Sun Set (SS).
Achievement of taste equivalence between the two formulations will imply that the taste and chewability information obtained with Sun Rise (SR) thus far can be assumed to be identical to that with Sun Set (SS).
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PROTOCOL OVERVIEW
Randomized, Single-centre, Double-blind, Two-period cross-
over trial in healthy gum chewing subjects
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GENERAL TRIAL INFORMATION
Trial PopulationMales and females Age 18-55 (inclusive)Number of subjects planned to screen: Up to 100Planned number of subjects to be randomized: 80Planned number of subjects to complete the trial: 60*
VisitsScreening (-14 to -3 days)Visits 2 & 3 (13-21 days between V2 & V3)Visit 4 (7-21 days from V3)
*Replacement of dropouts and withdrawals will take place in order to ensure that 60 subjects complete the trial.
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Primary objective: to test for taste equivalence between two
formulations of Sun Rise and Sunset based on AUCsr,0-10h,SD, Cmax,sr,SD, AUCss,0-10h,SD and Cmax,ss,SD.
OBJECTIVES
Secondary objectives:to compare the taste of the two
formulationsto evaluate the long term taste and
chewability of the two formulations
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PRIMARY ENDPOINTS
The onset of flavor AUCsr,0-10h,SD, area under the flavor concentration-time curve from 0 to 10 hours after single strip of gum
ENDPOINTS
The onset of flavor AUCss,0-10h,SD, area under the flavor concentration-time curve from 0 to 10 hours after single strip of gum
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TRIAL DESIGN Randomized, single–centre, double-blind, two period
cross over trial in healthy gum chewing subjects. Dose administration will occur at Visit 2,
randomization):Dose level of Sun Rise and Sun Set will be 1 strip of
gum Trial product will be administered as a single strip
placed into the mouth of the subject.Subjects will remain in the clinic until 12 hours
after dose administration.
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TRIAL DESIGN con’t Subjects will return to the clinic at 18 hours, 24
hours, and 36 hours after dose administration for analysis.
Subjects will have a wash out period of 13-21 days before returning to the clinic for the second treatment period (Visit 3).
Second treatment period is identical to the first treatment period.
Subjects will return to the clinic for a follow-up visit 7-21 days after dosing on Visit 3.
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TRIAL PRODUCTS
Sun Rise a pack of 5 strips
Sun Set a pack of 5 strips
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Key Inclusion Criteria
Male or female aged 18 - 55 years (both inclusive)
Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG, as judged by the Investigator
Able to chew gum for long hours and without swallowing it
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Key Exclusion Criteria History of 1st degree relatives that can’t chew gum
and walk Subject who has donated any blood or plasma in
the past month or more than 500 mL within 3 months prior to screening
Use of any competing gum within 3 weeks prior to screening
Use of any nicotine gum or weight reduction gum 3 weeks prior to screening
Smoker
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Withdrawal Criteria
The subject may be withdrawn from the trial at the discretion of the Investigator or the sponsor due to a safety concern of if judged non-compliant with trial procedures.
A subject must be withdrawn if the following applies: Pregnancy or intent to become pregnant Protocol deviation: If a protocol deviation or
concurrent illness occurs, which, in the clinical judgment of the Investigator, may invalidate the study by interfering with the comparability of the study, the subject will be withdrawn by the Investigator
Withdrawal of consent Blood donation during the course of the trial
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Assessments for Safety Physical Exams:
Complete/Full PE: Visits 1, 2, 3 and 4Vital signs: All visits ECG: Visits 1 and 4 (with rhythm strip)
Laboratory Assessments (biochemistry, hematology, urinalysis): Visits 1 and 4;
Pregnancy Testing: serum ß-HCG at Visits 1 and 4; urine test is acceptable for all other visits
Adverse event monitoring: All visits
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Laboratory Assessments
Local Laboratory: Hematology, Biochemistry, Urinalysis, Serum
Pregnancy Test
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Laboratory Assessment con’t
4Serum ß-hCG test (at screening and follow-up): urine stick test (at the dosing visits)
Screen Treatment
Follow-up Visit Visit 1 Visit 2 or 3 Visit 4 Day (within the visit for Visits 2 or 3)
-14 to -3 1 2, 3 4-6 21 to 43 Hematology/biochemistry and lipids X
X X
Pregnancy test (females only)4 X X X Urinalysis X X PK sampling6 X X X
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CONCOMITANT ILLNESS & MEDICATION
Concomitant Illness: Present at the start of the trial (e.g., first visit)
Concomitant Medication: Medication other than the trial products, taken during the trial, including screening and run-in periods
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Randomization & Blinding
At screening the subject must be assigned the lowest available subject number.
At randomization, the subject must always be assigned the visit box with the lowest available 6 digit number.
The subject will only have one box containing two visit boxes each containing two packages of gum.
Subject box 1 will be dispensed to the subject at Visit 2. The second visit box will remain in the subject box until Visit 3.
A replacement subject must be allocated to the same treatment sequence as the subject he replaces.
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Trial Supplies Trial Supplies Trial Products:
Sun Rise (SR) 1 strip of gum in a 5 strip packSun Set (SS) 1 strip of gum in a 5 strip pack
Packaging and Distribution:Double-blind1 subject box with two visit boxes
two visit boxes per subject box (Visit 2 and Visit 3)
each visit box with will have 2 packs of gumSubject box, visit box and gum pack will have
same number
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Delivery and Receipt Trial products will be shipped directly from vendor When dispatched, site will receive a Shipment
Notification Upon receipt, all products will be kept in secure,
limited access area. Check the materials against the shipping receipts (i.e.
quantity, numbers, etc.) Check that all materials are received in good
condition
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Trial Product Accountability
Trial Product accountability forms will be reviewed regularly
Trial product(s) will be stored in their recommended storage conditions
Any storage deviations will be reported immediately to the un-blinded CRA (this may result in quarantine of affected trial product)
Returned trial product will be accounted for by the CRA and destroyed onsite
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Monitoring
Case Report Forms (CRFs)
2 part NCR paper CRFs
Enter data into CRFs from source documentation
Corrections to CRFs
Affirmation Statement
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Monitoring con’t First MV within 2 weeks after the 1st subject is
screened
100% SDV (source data verification)
2-3 week intervals or more frequently, as required, depending on enrollment
Review Investigator Trial File (ITF) binders
Review regulatory documents
Collect CRFs and IRB documents
CRA to perform trial product accountability on a regular basis
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Questions?