Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to compare the "overall palatability" of the new orally
      disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the
      current available racemate PZQ tablets (reference) as assessed by means of human gustatory
      sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the
      incorporation of a 5 point facial hedonic scale).

      The secondary objectives are

        -  To obtain feedback from children regarding the taste of different formulations using an
           open ended questionnaire

        -  To document any discomfort or other observation in relation to acceptance of the study
           medication
    

Detailed description: 
      Initially pupils will be invited with their parents to school where they will be asked to
      give consent/assent in to the study and they will be instructed on how to follow up the taste
      study procedures. Enrollments will occur in the health facilities in Ikwiriri/Kibiti at the
      end of successive training. Informed consent from parents and guardians and assent from the
      child will be obtained before participation in the study. The study will be conducted in
      school children 6 years and older as recommended by the Committee for medical product for
      human use (CHMP) reflection paper: formulations of choice for the pediatric population.

      -This is a randomized, five-period cross over, single center swill and spit taste study where
      the drug will not be swallowed but will be spit out after tasting.

      On Day 1, the subjects will assess the palatability of the following arms in a randomized
      sequence:

        -  L-PZQ ODT (150 mg) put and disintegrated in the mouth

        -  Rac- PZQ ODT (150 mg) put and disintegrated in the mouth

      On Day 2, the subjects will assess the palatability of the following arms in a randomized
      sequence:

        -  L-PZQ ODT (150 mg) dispersed in water administered in the mouth cavity

        -  Rac- ODT (150 mg) dispersed in water administered in the mouth cavity

        -  150 mg current PZQ tablet (1/4 of a 600 mg tablet) crushed, dispersed in water and
           administered in the mouth cavity

      Gustatory sensation studies will be performed on the different formulations immediately after
      tasting and 2-5 min after the study drug has been spat out.

      All volunteers will be asked to place a mark along the line with the use of a 100 mm visual
      analogue scale (VAS) that incorporates a 5 points hedonic scale for "overall palatability".

      In addition, any discomfort or other observation in relation to acceptance of the study
      medication (Example: spitting out of the medicine) will be reported by the parents or
      investigator.

      An open ended questionnaire (description of mouth feeling and taste description) will be
      conducted for each child during the washout period. After the trial a therapeutic dose of
      Praziquantel will be made available to the local health council and management team to
      provide to the participating school.
    

Intervention name(s): L-PZQ ODT; Rac-PZQ ODT; L-PZQ ODT; Rac-PZQ ODT; Cesol®
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water; Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water; L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water; Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water; Cesol® tablet at a dose of 150 mg crushed in water
Other intervention name(s): MSC 2499550A; MSC1028703; MSC 2499550A; MSC1028703A; PZQ
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; L-PZQ; PZQ; MSC2499550A; Praziquantel