A Safety, Tolerability and Pharmacokinetic Study of CPP-115
Condition: Cocaine Dependency
Intervention: CPP-115; Placebo
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Tolerability

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
    

Eligibility 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.