A Phase 1 interventional study of CPP-115 and Placebo in Cocaine Dependency, sponsored by Catalyst Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Catalyst Pharmaceuticals, Inc. (part of Angelini Pharma) · Phase 1, Interventional, and Basic science
Primary Objective:
Secondary Objective:
Catalyst Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
First submitted before Catalyst Pharmaceuticals, Inc. became part of Angelini Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: CPP-115 · Drug: Placebo
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.
Drug: CPP-115 · Drug: Placebo
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.
Drug: CPP-115 · Drug: Placebo
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.
Drug: CPP-115 · Drug: Placebo
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.
Drug: CPP-115 · Drug: Placebo
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.
Drug: CPP-115 · Drug: Placebo
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
An equal volume of water mixed with juice will be administered.
Also known as: CPP-115
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.
Time frame: Days 1-3, 8 & 30
Phase 1 unit. Groups of 8 normal volunteer male subjects were screened \& returned to unit evening before they were to receive their specified dose.
| Milestone | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 2 (Repeat) | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 |
|---|---|---|---|---|---|---|---|
| Started | 8 | 8 | 7 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 7 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| participants | CPP-115 Dose 1 (5mg) | CPP-115 Dose 2 (13mg) | CPP-115 Dose 3 (32mg) | CPP-115 Dose 4 (80mg) | CPP-115 Dose 5 (200mg) | CPP-115 Dose 6 (500mg) |
|---|---|---|---|---|---|---|
| Safety of Single Oral Doses | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPP-115 Dose 1 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| CPP-115 Dose 2 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| CPP-115 Dose 3 | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| CPP-115 Dose 4 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| CPP-115 Dose 5 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| CPP-115 Dose 6 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 |
|---|---|---|---|---|---|---|
| Frequent bowel movementsGastrointestinal disorders | 0/6 | 0/6 | 1/5 | 0/6 | 0/6 | 0/6 |
| Infusion site painGeneral disorders | 0/6 | 0/6 | 0/5 | 0/6 | 1/6 | 0/6 |
| Blood CPK increasedInvestigations | 0/6 | 1/6 | 0/5 | 0/6 | 0/6 | 1/6 |
| GroinMusculoskeletal and connective tissue disorders | 0/6 | 0/6 | 0/5 | 0/6 | 1/6 | 0/6 |
Subjects randomized to drug had plasma and urine levels of drug analyzed to produce pharmacokinetic profiles (e.g. time to maximum concentration (Cmax), half life (t1/2), area under the curve (AUC)
| Age, Categorical(Participants) | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 2 (Repeat) | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 5 | 6 | 6 | 6 | 6 | 41 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 2 (Repeat) | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 35.8 ± 13.01 | 32.6 ± 5.67 | 35.2 ± 12.11 | 38.8 ± 4.83 | 40.8 ± 9.93 | 38.0 ± 10.6 | 35.5 ± 7.5 | 36.8 ± 9.09 |
| Sex: Female, Male(Participants) | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 2 (Repeat) | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 6 | 6 | 5 | 6 | 6 | 6 | 6 | 41 |
| Region of Enrollment(participants) | CPP-115 Dose 1 | CPP-115 Dose 2 | CPP-115 Dose 2 (Repeat) | CPP-115 Dose 3 | CPP-115 Dose 4 | CPP-115 Dose 5 | CPP-115 Dose 6 | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 6 | 6 | 5 | 6 | 6 | 6 | 6 | 41 |
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Catalyst Pharmaceuticals, Inc. →