A Safety, Tolerability and Pharmacokinetic Study of CPP-115

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cocaine Dependency

Intervention / Treatment
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* Drug: CPP-115
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CPP-115 Dose 1<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|
| Other: CPP-115 Dose 2<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|
| Other: CPP-115 Dose 3<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|
| Other: CPP-115 Dose 4<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|
| Other: CPP-115 Dose 5<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|
| Other: CPP-115 Dose 6<br>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<br>* Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.<br>Drug: Placebo<br>* An equal volume of water mixed with juice will be administered.<br>* Other names: CPP-115;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 1-3, 8 & 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Tolerability