CC100: Safety and Tolerability of Single Doses

• Sponsor: Chemigen, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02050334
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 1.2

Study Details

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
• 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: Nov 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Feb 1, 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 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

Outcome Measures

Primary Outcome Measures

1. Unsolicited Adverse Event Reports [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) [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) [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chemigen, LLC
• ClinicalTrials.gov Identifier: NCT02050334
• Other Study ID Numbers: CC100A
• First Posted: Jan 30, 2014
• Last Update Posted: Apr 30, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Chemigen, LLC: Phase 1; Healthy Volunteer; Safety; Healthy Volunteer Safety Study
• Additional relevant MeSH terms: Caffeic acid

Study Results

Participant Flow

Arm/Group Title	CC100 (3 Single Doses)	CC100 (2 Single Doses) & Placebo(1 Dose)
Arm/Group Description	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. CC100	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. CC100 Placebo
Period Title: Overall Study
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CC100 (3 Single Doses)	CC100 (2 Single Doses) & Placebo(1 Dose)	Total
Arm/Group Description	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. CC100	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. CC100 Placebo	Total of all reporting groups
Overall Participants	9	9	18
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	9 100%	18 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	3 33.3%	2 22.2%	5 27.8%
Male	6 66.7%	7 77.8%	13 72.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	9 100%	9 100%	18 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 22.2%	1 11.1%	3 16.7%
White	7 77.8%	8 88.9%	15 83.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	9 100%	18 100%

Outcome Measures

1. Primary Outcome

Title	Unsolicited Adverse Event Reports
Description	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	Minimum of 24 hours after each dose.

Outcome Measure Data

Analysis Population Description

All 18 subjects analyzed, per protocol.

Arm/Group Title	CC100 (3 Single Doses)	CC100 (2 Single Doses) & Placebo(1 Dose)
Arm/Group Description	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. CC100	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. CC100 Placebo
Measure Participants	9	9
Number [Unsolicited Adverse Event Reports]	3	4

2. Secondary Outcome

Title	Pharmacokinetics (PK)
Description	Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame	0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100

Outcome Measure Data

Analysis Population Description

16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.

Arm/Group Title	CC100 Single Doses
Arm/Group Description	CC100: 2, 5, 10, and 20 mg/kg doses.
Measure Participants	10
Mean (Standard Error) [hours]	2.7 (2.3)

3. Secondary Outcome

Title	Half-Life (t1/2)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100

Outcome Measure Data

Analysis Population Description

16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.

Arm/Group Title	CC100 Single Doses
Arm/Group Description	CC100: 2, 5, 10, and 20 mg/kg doses.
Measure Participants	10
Mean (Standard Error) [hours]	18.5 (14.2)

Adverse Events

Arm/Group Title	CC100 (3 Single Doses)		CC100 (2 Single Doses) & Placebo(1 Dose)
Arm/Group Description	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. CC100		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. CC100 Placebo
All Cause Mortality
	CC100 (3 Single Doses)		CC100 (2 Single Doses) & Placebo(1 Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CC100 (3 Single Doses)		CC100 (2 Single Doses) & Placebo(1 Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	CC100 (3 Single Doses)		CC100 (2 Single Doses) & Placebo(1 Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)		4/9 (44.4%)
Infections and infestations
urinary tract infections	1/9 (11.1%)		0/9 (0%)
Fever	0/9 (0%)		1/9 (11.1%)
Musculoskeletal and connective tissue disorders
Back pain	1/9 (11.1%)		0/9 (0%)
Nervous system disorders
Headache	1/9 (11.1%)		3/9 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.