A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to
      compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co
      administration with omeprazole, a proton pump inhibitor.

      The study will consist of a screening phase, a baseline phase, four treatment periods, and a
      follow up phone call five days (± 1 day) after discharge.
    

Detailed description: 
      Subjects will be consented and screened within 21 days of dosing. They will undergo routine
      screening procedures including physical examinations (PE), 12 lead electrocardiograms (ECGs),
      vital sign measurements, clinical laboratory safety tests (clinical chemistry, haematology,
      urinalysis), pregnancy tests for females, and serology/drug/alcohol screens.

      Eligible subjects will return to the clinic site on Day -1 for baseline safety assessments.
      After an overnight fast of at least 10 hours, subjects will be assigned randomly to one of
      six treatment sequences which will determine fasting status and the order in which treatments
      will be administered.

      Subjects in the fasted arm will receive either a single 160 mg tablet of GED 0301 or four 40
      mg tablets of GED 0301, with approximately 240 mL of room temperature, non-carbonated water.

      Subjects in the fed arm will be required to fast overnight for at least 10 hours. On the
      morning of dosing, these subjects will be served a high-fat meal. The meal should be entirely
      consumed within 20 minutes of being served. Dosing of a single160 mg tablet of GED 0301 will
      occur within 30 minutes (± 5 minutes) after the start of the meal.

      During the fourth period, subjects will receive once daily oral doses of 40 mg omeprazole for
      6 days (Days 10 through 16). Subjects will fast on the evening of the fourth day for at least
      10 hours prior to receiving the last treatment, which is a single dose of 160 mg GED 0301
      together with one 40 mg oral dose of omeprazole (Day 15). On Day 16, subjects will take the
      last dose of omeprazole.

      Serial blood sampling for the determination of GED 0301 levels in plasma will be performed
      during each period for 48 hours post dose.

      Subjects will be domiciled at the clinic site from Day 1 of Period 1 until Day 17. All
      subjects will be discharged from the clinic site on Day 17 when all required safety and PK
      procedures have been completed.

      A follow up phone call will occur five days (± 1 day) after discharge from the clinic center.

      The study will be conducted in compliance with Good Clinical Practice (GCP), as described in
      International Conference on Harmonisation (ICH) Guideline E6 and in accordance with the
      general ethical principles outlined in the Declaration of Helsinki. The study will receive
      approval from an EC prior to commencement. The Investigator will conduct all aspects of this
      study in accordance with applicable national, state, and local laws of the pertinent
      regulatory authorities.
    

Intervention name(s): GED-0301; Omeprazole
Intervention type(s): Drug; Drug
Other intervention name(s): Mongersen
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Pharmacokinetics; Food Effect; Proton Pump; GED-0301; Mongersen