Status:
COMPLETED
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
Lead Sponsor:
Catalyst Pharmaceuticals, Inc.
Conditions:
Cocaine Dependency
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 administ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01493596
Start Date
December 1 2011
End Date
August 1 2012
Last Update
April 20 2021
Active Locations (1)
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1
Clinilabs, Inc.
New York, New York, United States, 10019