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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.

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Presentation on theme: "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."— Presentation transcript:

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. 1Version: Final 14-Apr-2010

2 AGENDA Part I  Study Team  Trial Timelines  Overview of  Protocol Review  Trial Products  Inclusion / Exclusion Criteria  Visit Procedures  AEs, SAEs,  Questions Part II  Investigational drug  Monitoring  Questions 2Version: Final 14-Apr-2010

3 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 3Version: Final 14-Apr-2010

4 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 Version: Final 14-Apr-2010

5 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 5Version: Final 14-Apr-2010

6 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 ) 6Version: Final 14-Apr-2010

7 RATIONALE  The 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). 7Version: Final 14-Apr-2010

8 PROTOCOL OVERVIEW Randomized, Single-centre, Double-blind, Two-period cross- over trial in healthy gum chewing subjects 8Version: Final 14-Apr-2010

9 GENERAL TRIAL INFORMATION Trial Population  Males and females  Age (inclusive)  Number of subjects planned to screen: Up to 100  Planned number of subjects to be randomized: 80  Planned number of subjects to complete the trial: 60* Visits  Screening (-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. 9Version: Final 14-Apr-2010

10  Primary objective:  to test for taste equivalence between two formulations of Sun Rise and Sunset based on AUC sr,0-10h,SD, C max,sr,SD, AUC ss,0-10h,SD and C max,ss,SD. OBJECTIVES  Secondary objectives:  to compare the taste of the two formulations  to evaluate the long term taste and chewability of the two formulations 10Version: Final 14-Apr-2010

11 PRIMARY ENDPOINTS  The onset of flavor AUC sr,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 AUC ss,0-10h,SD, area under the flavor concentration-time curve from 0 to 10 hours after single strip of gum 11Version: Final 14-Apr-2010

12 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. 12Version: Final 14-Apr-2010

13 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 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. 13Version: Final 14-Apr-2010

14 TRIAL PRODUCTS  Sun Rise a pack of 5 strips  Sun Set a pack of 5 strips 14Version: Final 14-Apr-2010

15 Key Inclusion Criteria  Male or female aged 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 15Version: Final 14-Apr-2010

16 Key Exclusion Criteria  History of 1 st 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 16Version: Final 14-Apr-2010

17 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 17Version: Final 14-Apr-2010

18 Assessments for Safety  Physical Exams:  Complete/Full PE: Visits 1, 2, 3 and 4  Vital 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 18Version: Final 14-Apr-2010

19 Laboratory Assessments  Local Laboratory:  Hematology, Biochemistry, Urinalysis, Serum Pregnancy Test 19Version: Final 14-Apr-2010

20 Laboratory Assessment con’t 20Version: Final 14-Apr-2010

21 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 21Version: Final 14-Apr-2010

22 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. 22Version: Final 14-Apr-2010

23 Trial Supplies  Trial Supplies  Trial Products:  Sun Rise (SR) 1 strip of gum in a 5 strip pack  Sun Set (SS) 1 strip of gum in a 5 strip pack  Packaging and Distribution:  Double-blind  1 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 gum  Subject box, visit box and gum pack will have same number 23Version: Final 14-Apr-2010

24 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 24Version: Final 14-Apr-2010

25 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 25Version: Final 14-Apr-2010

26 Monitoring Case Report Forms (CRFs)  2 part NCR paper CRFs  Enter data into CRFs from source documentation  Corrections to CRFs  Affirmation Statement 26Version: Final 14-Apr-2010

27 Monitoring con’t  First MV within 2 weeks after the 1 st 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 27Version: Final 14-Apr-2010

28 Questions? 28Version: Final 14-Apr-2010


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