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A Clinical Phase I Study on GIC-1001 in Healthy Volunteers

NCT01738425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-07-19

No results posted yet for this study

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.

Conditions

  • Colonic Diseases

Interventions

DRUG

GIC-1001; 125 mg oral tablets

Single ascending doses (SAD) from 125 mg to 1000 mg; Multiple ascending doses from 125 mg to 500 mg, TID over 7 successive days

DRUG

GIC-1001 matching placebo

Single ascending doses (SAD) \[equivalent to active arm, 125 mg to 1000 mg\] Multiple ascending doses, TID over 7 successive days \[equivalent to the active arm, 125 mg to 500 mg\]

Sponsors & Collaborators

  • gicare Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738425 on ClinicalTrials.gov