IU Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
NCT Number: NCT02050334
The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
Indianapolis, Indiana, 46202, United States
Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CC100 reconstituted in diluent
Other names: synthetic caffeic acid phenethylester
Diluent. Amount to match CC100 dose.
Other names: Inactive vehicle
Time frame: Minimum of 24 hours after each dose.
Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Chemigen, LLC
Industry
Protocol CC100A CC100: Safety and Tolerability of Single Doses
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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