CC100: Safety and Tolerability of Single Doses

Protocol CC100A 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CC100; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Neuroscience Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: synthetic caffeic acid phenethylester; Drug: Placebo; Diluent. Amount to match CC100 dose.; Other Names: Inactive vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unsolicited Adverse Event Reports	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.	Minimum of 24 hours after each dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK)	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100

Collaborators and Investigators

• Sponsor: Chemigen, LLC
• Investigators: Principal Investigator: Robert M Pascuzzi, MD, IU Health Physicians - Neurology

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Healthy Volunteer; Phase 1; Healthy Volunteer Safety Study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Caffeic acid
• Other Study ID Numbers: CC100A