CC100: Safety and Tolerability of Single Doses

• ClinicalTrials.gov Identifier: NCT02050334
• Recruitment Status: Completed
• First Posted: January 30, 2014
• Results First Posted: April 29, 2015
• Last Update Posted: April 30, 2015
• Sponsor: Chemigen, LLC
• Information provided by (Responsible Party): Chemigen, LLC

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: CC100; Drug: Placebo	Phase 1

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Protocol CC100A CC100: Safety and Tolerability of Single Doses
• Study Start Date: November 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: CC100 (3 single doses); CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.	Drug: CC100; CC100 reconstituted in diluent; Other Name: synthetic caffeic acid phenethylester
Experimental: CC100 (2 single doses) & placebo(1 dose); CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.	Drug: CC100; CC100 reconstituted in diluent; Other Name: synthetic caffeic acid phenethylester; Drug: Placebo; Diluent. Amount to match CC100 dose.; Other Name: Inactive vehicle

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Indiana

IU Health Neuroscience Center

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Chemigen, LLC

Investigators

• Principal Investigator: Robert M Pascuzzi, MD; IU Health Physicians - Neurology

More Information

• Responsible Party: Chemigen, LLC
• ClinicalTrials.gov Identifier: NCT02050334
• Other Study ID Numbers: CC100A
• First Posted: January 30, 2014
• Results First Posted: April 29, 2015
• Last Update Posted: April 30, 2015
• Last Verified: April 2015

Keywords provided by Chemigen, LLC:

Phase 1; Healthy Volunteer; Safety; Healthy Volunteer Safety Study

Additional relevant MeSH terms:

Caffeic acid; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs