Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      Cross-over, tolerability study with healthy subjects taking Zavesca in combination with
      Florastor. Forty-two subjects will be randomized to one of two treatment sequences of Zavesca
      with Florastor and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK
      endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected
      throughout the seventy-four day study.
    

Detailed description: 
      This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, two period /
      two treatment, cross-over study with GI tolerability, safety, and PK assessments. A total of
      42 healthy subjects will be enrolled. At least 30% of female subjects are expected to be
      enrolled. Subjects will participate in 2 treatment periods (Treatment Period 1 and Treatment
      Period 2), separated by a 10- to 14-day washout.

      Subjects will be randomly allocated to the treatment sequence, A-B or B-A:

        -  Treatment A: Placebo of S. boulardii 500 mg twice a day (b.i.d.) from Day 1 to Day 16 of
           the treatment period, and miglustat capsules 100 mg t.i.d. from Day 3 to Day 16.

        -  Treatment B: S. boulardii 500 mg b.i.d. from Day 1 to Day 16 of the treatment period,
           and miglustat capsules 100 mg t.i.d. from Day 3 to Day 16.

      To minimize possible carry-over effect, a 10 to 14-day washout period is added between
      Treatment Period 1 and Period 2. Steady-state PK evaluations will occur at the end of Period
      1 and Period 2 requiring full-day clinic stays by each subject.

      The planned study duration per subject will be approximately 46 days (not inclusive of
      Screening and serious adverse event [SAE] follow-up periods). However, the duration may be up
      to 53 days if all visit windows are utilized. The Screening period may last up to 30 days
      prior to the first administration of study medication. Telephone follow-up will occur within
      48-72 hours after last study drug dose in each treatment period to record SAEs/AEs and
      concomitant medications. In addition, subjects will be followed up 30 days after permanent
      study drug discontinuation for ongoing AEs and new SAEs via a telephone consult.
    

Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).; Florastor® capsules dosed at 1000 mg daily (two 250 mg capsules two times per day).
Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).
Other intervention name(s): Florastor® placebo.; Zavesca® capsules.; Florastor® capsules.; Zavesca® capsules.
Intervention MeSH terms: Miglustat; 1-Deoxynojirimycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: diarrhea