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CC100: Safety and Tolerability of Single Doses

NCT ID: NCT02050334

Last Updated: 2015-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Phase 1 Healthy Volunteer Safety Healthy Volunteer Safety Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

CC100

Intervention Type DRUG

CC100 reconstituted in diluent

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.

Group Type EXPERIMENTAL

CC100

Intervention Type DRUG

CC100 reconstituted in diluent

Placebo

Intervention Type DRUG

Diluent. Amount to match CC100 dose.

Interventions

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CC100

CC100 reconstituted in diluent

Intervention Type DRUG

Placebo

Diluent. Amount to match CC100 dose.

Intervention Type DRUG

Other Intervention Names

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synthetic caffeic acid phenethylester Inactive vehicle

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chemigen, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert M Pascuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

IU Health Physicians - Neurology

Locations

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IU Health Neuroscience Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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CC100A

Identifier Type: -

Identifier Source: org_study_id