HealthyPhase 1NCT02050334
CC100: Safety and Tolerability of Single Doses
A Phase 1 study testing CC100 in people with Healthy, run by Chemigen, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CC100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- CC100, Placebo
- Keywords
- Phase 1, Healthy Volunteer, Safety, Healthy Volunteer Safety Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC100Drug
Also called synthetic caffeic acid phenethylester
CC100 reconstituted in diluent
PlaceboDrug
Also called Inactive vehicle
Diluent. Amount to match CC100 dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CC100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Minimum of 24 hours after each dose.
Secondary outcomes (2)
Pharmacokinetics (PK)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 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.
Measured: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chemigen, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert M Pascuzzi, MD, Principal investigator, IU Health Physicians - Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050334
- Sponsor's protocol ID
- CC100A
- Status last verified
- Apr 2015
- First submitted
- 29 Jan 2014
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol CC100A CC100: Safety and Tolerability of Single Doses
- ClinicalTrials.gov ID
- NCT02050334
- Acronym / sponsor ID
- CC100A
- Conditions
- Healthy
- Keywords
- Phase 1, Healthy Volunteer, Safety, Healthy Volunteer Safety Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chemigen, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 29 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC100 (3 single doses) | Experimental | Drug: CC100CC100 (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 (2 single doses) & placebo(1 dose) | Experimental | Drug: CC100, Drug: PlaceboCC100 (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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC100Also: synthetic caffeic acid phenethylesterCC100 reconstituted in diluent | Drug | CC100 (2 single doses) & placebo(1 dose), CC100 (3 single doses) |
| PlaceboAlso: Inactive vehicleDiluent. Amount to match CC100 dose. | Drug | CC100 (2 single doses) & placebo(1 dose) |
Primary outcome
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.
2 secondary outcomes
Pharmacokinetics (PK)
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Half-Life (t1/2)
Time frame: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Pascuzzi, MD principal investigator
IU Health Physicians - Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC100 in people with Healthy, run by Chemigen, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsolicited Adverse Event Reports (time frame: Minimum of 24 hours after each dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.