A Clinical Phase I Study on GIC-1001 in Healthy Volunteers
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I
      clinical study are to evaluate the safety and tolerability of five (5) single and four (4)
      multiple increasing oral doses of GIC-1001 compared to placebo, and to evaluate the
      pharmacokinetics of GIC-1001 following single and multiple-dose administration in 80 healthy,
      18-50 years old male and female subjects. Moreover, the effect of food on the
      pharmacokinetics of GIC-1001 in healthy subjects will be assessed. This study is designed
      with an integrated, adaptive approach which allows the evaluation of single and multiples
      doses of GIC-1001 in a progressive, overlapped fashion.
    

Detailed description: 
      Each cohort of enrolled healthy volunteers will include a total of eight (8) subjects: Six
      (6) subjects randomized to the active GIC-1001 and two (2) subjects randomized to a matching
      placebo.

      Part 1: Single Doses Cohort A: Single dose of 125 mg of GIC-1001 or placebo; Cohort B: Single
      dose of 250 mg of GIC-1001 or placebo; Cohort C: Single dose of 375 mg of GIC-1001 or
      placebo; Cohort D: Single dose of 500 mg of GIC-1001 or placebo; and Cohort E: Single dose of
      1000 mg of GIC-1001 or placebo. Up to 21 blood samples will be obtained over a 36 hour
      period.

      Part 2: Multiple Doses, three times a day (TID) during 7 consecutive days; Cohort F: Multiple
      doses of 125 mg of GIC-1001 or placebo; Cohort G: Multiple doses of 250 mg of GIC-1001 or
      placebo; Cohort H: Multiple doses of 375 mg of GIC-1001 or placebo; and Cohort I: Multiple
      doses of 500 mg of GIC-1001 or placebo. Up to 18 blood samples will be obtained over a 7 day
      period.

      Part 3: one single dose of GIC-1001 to be selected for the Food Effect cross-over evaluation.
      A total of 16 blood samples will be obtained over a 36 hour period.

      Physical exams, 24 hour cardiac monitoring, and a complete battery of biochemical and
      hematological lab tests will be done to assess the safety and tolerability of GIC-1001 in all
      dosing cohorts.
    

Intervention name(s): GIC-1001; 125 mg oral tablets; GIC-1001 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses (SAD) from 125 mg to 1000 mg;
Multiple ascending doses from 125 mg to 500 mg, TID over 7 successive days; Single ascending doses (SAD) [equivalent to active arm, 125 mg to 1000 mg]
Multiple ascending doses, TID over 7 successive days [equivalent to the active arm, 125 mg to 500 mg]
Other intervention name(s): hydrogen sulfide releasing opioid agonist; Same tablet-based excipients, without GIC-1001 (active)
Intervention MeSH terms: Hydrogen Sulfide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GIC-1001; opioid agonist; sulfide; colonoscopy; gicare; Phase I; safety; tolerability; pharmacokinetics; healthy subjects; single ascending dose; multiple ascending dose; SAD; MAD; food effect