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OpenTrials
Completed

NCT Number: NCT02050334

CC100: Safety and Tolerability of Single Doses

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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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.

Exclusion criteria

  • Have serious or unstable illnesses as determined by the investigator.
  • Have current or a history of asthma, or severe drug allergies or pollen allergy.
  • Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study.
  • Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection.
  • Have laboratory test values that are considered clinically significant as determined by the investigator.
  • Have ECG abnormalities that are clinically significant.
  • Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing.
  • Have a history of chronic alcohol or drug abuse within the past 2 years.

Treatment and study plan

CC100

Drug

CC100 reconstituted in diluent

Other names: synthetic caffeic acid phenethylester

Placebo

Drug

Diluent. Amount to match CC100 dose.

Other names: Inactive vehicle

Primary outcomes

  1. Unsolicited Adverse Event Reports

    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.

Secondary outcomes

  1. Pharmacokinetics (PK)

    Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  2. Half-Life (t1/2)

    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.

Sponsors and collaborators

Lead sponsor

Chemigen, LLC

Industry

Registry information

Official study title

Protocol CC100A CC100: Safety and Tolerability of Single Doses

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 30, 2014
Registry last updated
Apr 30, 2015

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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