- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493596
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
March 25, 2021 updated by: Catalyst Pharmaceuticals, Inc.
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10019
- Clinilabs, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: CPP-115 Dose 1
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.
|
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.
Other Names:
|
OTHER: CPP-115 Dose 2
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.
|
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.
Other Names:
|
OTHER: CPP-115 Dose 3
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.
|
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.
Other Names:
|
OTHER: CPP-115 Dose 4
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.
|
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.
Other Names:
|
OTHER: CPP-115 Dose 5
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.
|
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.
Other Names:
|
OTHER: CPP-115 Dose 6
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Days 1-3, 8 & 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mardik Donikyan, DO, Clinilabs, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
November 28, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (ESTIMATE)
December 16, 2011
Study Record Updates
Last Update Posted (ACTUAL)
April 20, 2021
Last Update Submitted That Met QC Criteria
March 25, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CPP-115-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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