Colonic Diseases Clinical Trial
Official title:
A Double-Blind, Placebo Controlled, Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GIC-1001 in Normal Healthy Volunteers
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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