NCT01651234 - A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

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"

Trial Locations (1)

66211

Quintiles Phase1 Unit, Overland Park