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A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers

NCT01651234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-08-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\\profile.

Conditions

  • Healthy Male

Interventions

DRUG

GCC-4401

* Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use * single dose * dosage * Cohort 1: 2.5-mg GCC-4401C * Cohort 2: 5.0-mg GCC-4401C * Cohort 3: 10-mg GCC-4401C * Cohort 4: 20-mg GCC-4401C * Cohort 5: 40-mg GCC-4401C * Cohort 6: 80-mg GCC-4401C

DRUG

GCC-4401C

* Capsule, identical in appearance to GCC-4401C, for oral use * single dose * dosage * Cohort 1: 2.5-mg matching placebo * Cohort 2: 5.0-mg matching placebo * Cohort 3: 10-mg matching placebo * Cohort 4: 20-mg matching placebo * Cohort 5: 40-mg matching placebo * Cohort 6: 80-mg matching placebo

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Green Cross Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

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 NCT01651234 on ClinicalTrials.gov