CC100: Safety and Tolerability of Single Doses

NCT02050334 | Completed Phase 1 Results

• 1 other identifier: CC100A
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics (PK)

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

• Half-Life (t1/2)

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

Study Arms (2)

CC100 (3 single doses)

EXPERIMENTAL

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 (2 single doses) & placebo(1 dose)

EXPERIMENTAL

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; Drug: Placebo

Interventions

CC100 DRUG

CC100 reconstituted in diluent

Also known as: synthetic caffeic acid phenethylester

CC100 (2 single doses) & placebo(1 dose); CC100 (3 single doses)

Placebo DRUG

Diluent. Amount to match CC100 dose.

Also known as: Inactive vehicle

CC100 (2 single doses) & placebo(1 dose)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chemigen, LLC: lead

Study Sites (1)

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Consultant
• Organization: Chemigen

farlowds@yahoo.com

317 293-0852

Study Officials

• Robert M Pascuzzi, MD

  IU Health Physicians - Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 30, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 30, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-04

Locations

US (1)