Text Size

A Safety, Tolerability and Pharmacokinetic Study of CPP-115

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:
NCT01493596
First received: November 28, 2011
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine Dependency
 Drug: CPP-115
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Further study details as provided by Catalyst Pharmaceutical Partners, Inc:

Primary Outcome Measures:
  • Safety of single oral doses [ Time Frame: Days 1-3, 8 & 30 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Comparative pharmacokinetic profiles of ascending single oral doses [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
    Profile comparisons based on plasma concentrations, including: Cmax - Maximum observed plasma concentration; Tmax - Time to maximum observed plasma concentration; AUC(0-∞) - Area under the concentration-time curve from time zero extrapolated to infinite time; & AUC(0-last) - Area under the concentration-time curve from time zero to the last measurable concentration.


Estimated Enrollment: 48
Study Start Date: December 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115
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.
 Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Other Name: CPP-115
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Name: CPP-115

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Willing and able to give written informed consent and comply with study procedures and requirements.
  2. Males, age 18 to 65 years.
  3. Body Mass Index between 19 and 32 kg/m2.
  4. 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)]).
  5. Willing and able to abstain from drug, alcohol, and tobacco use during study participation.

Exclusion Criteria:

  1. Medical history and/or findings on physical examination indicating the presence of clinically significant illness.
  2. Clinically significant abnormalities of vital signs or clinical laboratory results (including hematology, chemistry, and urinalysis).
  3. 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.
  4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
  5. Clinically significant ECG abnormalities including QTc ≥ 450 msec.
  6. 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.
  7. Use of any prescription, illegal, or investigational drug within 28 days prior to Day 1.
  8. 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.
  9. Use of alcohol, caffeine, or poppy seed-containing foods or beverages within 72 hours prior to Day 1.
  10. History of recent (within 6 months) drug or alcohol abuse, as defined in DSM IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition).
  11. 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.
  12. Positive serology for the surface antigen of Hepatitis B (HBsAg), Hepatitis C (anti HCV), or human immunodeficiency virus (HIV) antibody screen.
  13. 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.
  14. Receipt of blood products within 2 months prior to Screening.
  15. Any condition or other reason that, in the opinion of the Investigator, would render the subject unsuitable for the clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493596

Locations
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
Sponsors and Collaborators
Catalyst Pharmaceutical Partners, Inc
Investigators
Principal Investigator: Mardik Donikyan, DO Clinilabs, Inc
  More Information

No publications provided

Responsible Party: Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier: NCT01493596     History of Changes
Other Study ID Numbers: CPP-115-0001
Study First Received: November 28, 2011
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Catalyst Pharmaceutical Partners, Inc:
Safety
Tolerability

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013