Cocaine DependencyPhase 1NCT01493596
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
A Phase 1 study testing CPP-115 in people with Cocaine Dependency, run by Catalyst Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Primary Objective: To evaluate the safety and tolerability of ascending single oral doses of CPP-115 Secondary Objective: To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependency
- What is being tested?
- CPP-115
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Aug 2012
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent and comply with study procedures and requirements.
- Males, age 18 to 65 years.
- Body Mass Index between 19 and 32 kg/m2.
- Normal systolic blood pressure (BP [90-140 mmHg]), diastolic BP (50 90 mmHg) and heart rate (HR [resting HR 40-90 beats per minute (bpm)]).
- Willing and able to abstain from drug, alcohol, and tobacco use during study participation.
Who cannot join
- Medical history and/or findings on physical examination indicating the presence of clinically significant illness.
- Clinically significant abnormalities of vital signs or clinical laboratory results (including hematology, chemistry, and urinalysis).
- Presence or recent history (within 28 days prior to Screening) of active and clinically significant (as judged by the Investigator) gastrointestinal, renal, cardiovascular, hepatic, metabolic, allergic, dermatologic, hematologic, pulmonary, neurological or psychiatric illness or disorder.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Clinically significant ECG abnormalities including QTc ≥ 450 msec.
- Use of any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Screening.
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- Use of any prescription, illegal, or investigational drug within 28 days prior to Day 1.
- Use of any over-the-counter (OTC) drug, including vitamins, minerals, dietary/herbal supplements, or grapefruit or grapefruit juice within 14 days prior to Day 1.
- Use of alcohol, caffeine, or poppy seed-containing foods or beverages within 72 hours prior to Day 1.
- History of recent (within 6 months) drug or alcohol abuse, as defined in DSM IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition).
- Positive urine drug screen, urine cotinine test, or alcohol breath test at Screening or check-in to the clinical study unit (CSU). Subjects with results believed to be false positives can be allowed to screen while results are retested at a specialized laboratory.
- Positive serology for the surface antigen of Hepatitis B (HBsAg), Hepatitis C (anti HCV), or human immunodeficiency virus (HIV) antibody screen.
- Donation of blood or plasma to a blood bank or for a clinical study (except for study screening) within 28 days prior to Day 1.
- Receipt of blood products within 2 months prior to Screening.
- Any condition or other reason that, in the opinion of the Investigator, would render the subject unsuitable for the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of CPP-115 Solution Administered Orally to Healthy Volunteers
Primary Objective:
- To evaluate the safety and tolerability of ascending single oral doses of CPP-115
Secondary Objective:
- To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
- Conditions
- Cocaine Dependency
- Being tested
- CPP-115, Placebo
- Keywords
- Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-115Drug
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
PlaceboDrug
Also called CPP-115
An equal volume of water mixed with juice will be administered.
| Study group | Role | What they receive |
|---|---|---|
| CPP-115 Dose 1 | Other | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
| CPP-115 Dose 2 | Other | 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
| CPP-115 Dose 3 | Other | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
| CPP-115 Dose 4 | Other | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
| CPP-115 Dose 5 | Other | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
| CPP-115 Dose 6 | Other | Each dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. Receives: Drug: CPP-115; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Single Oral Doses
Number of subjects with clinically significant changes in vital signs, ECG abnormalities changes of cardiac rhythm, serious or severe AEs, and/or clinically significant changes in clinical laboratory evaluations.
Measured: Days 1-3, 8 & 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionAug 2012
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 Cocaine DependencyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mardik Donikyan, DO, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493596
- Sponsor's protocol ID
- CPP-115-0001
- Status last verified
- Mar 2021
- First submitted
- 28 Nov 2011
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of CPP-115 Solution Administered Orally to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01493596
- Acronym / sponsor ID
- CPP-115-0001
- Conditions
- Cocaine Dependency
- Keywords
- Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the safety and tolerability of ascending single oral doses of CPP-115
Secondary Objective:
- To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CPP-115 Dose 1 | Other | Drug: CPP-115, Drug: PlaceboEach dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 2 | Other | Drug: CPP-115, Drug: Placebo2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 3 | Other | Drug: CPP-115, Drug: PlaceboEach dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 4 | Other | Drug: CPP-115, Drug: PlaceboEach dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 5 | Other | Drug: CPP-115, Drug: PlaceboEach dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
| CPP-115 Dose 6 | Other | Drug: CPP-115, Drug: PlaceboEach dose cohort will consist of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects to receive matching placebo. Progression to the next higher dose level will be contingent upon demonstration of a satisfactory assessment of the data from the previous dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent and comply with study procedures and requirements.
- Males, age 18 to 65 years.
- Body Mass Index between 19 and 32 kg/m2.
- Normal systolic blood pressure (BP [90-140 mmHg]), diastolic BP (50 90 mmHg) and heart rate (HR [resting HR 40-90 beats per minute (bpm)]).
- Willing and able to abstain from drug, alcohol, and tobacco use during study participation.
Key exclusion criteria (15 listed)
- Medical history and/or findings on physical examination indicating the presence of clinically significant illness.
- Clinically significant abnormalities of vital signs or clinical laboratory results (including hematology, chemistry, and urinalysis).
- Presence or recent history (within 28 days prior to Screening) of active and clinically significant (as judged by the Investigator) gastrointestinal, renal, cardiovascular, hepatic, metabolic, allergic, dermatologic, hematologic, pulmonary, neurological or psychiatric illness or disorder.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Clinically significant ECG abnormalities including QTc ≥ 450 msec.
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 |
|---|---|---|
| CPP-115Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. | Drug | CPP-115 Dose 1, CPP-115 Dose 2, CPP-115 Dose 3, CPP-115 Dose 4, CPP-115 Dose 5, CPP-115 Dose 6 |
| PlaceboAlso: CPP-115An equal volume of water mixed with juice will be administered. | Drug | CPP-115 Dose 1, CPP-115 Dose 2, CPP-115 Dose 3, CPP-115 Dose 4, CPP-115 Dose 5, CPP-115 Dose 6 |
Primary outcome
Safety of Single Oral Doses
Time frame: Days 1-3, 8 & 30
Number of subjects with clinically significant changes in vital signs, ECG abnormalities changes of cardiac rhythm, serious or severe AEs, and/or clinically significant changes in clinical laboratory evaluations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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.
Mardik Donikyan, DO principal investigator
Clinilabs, Inc.
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 CPP-115 in people with Cocaine Dependency, run by Catalyst Pharmaceuticals, Inc. 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 5 inclusion and 15 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 20 Apr 2021. 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 20 Apr 2021). 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?
Safety of Single Oral Doses (time frame: Days 1-3, 8 & 30). 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 20 Apr 2021.