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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPP-115 Dose 1 | Other | 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. |
|
| CPP-115 Dose 2 | Other | 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. |
|
| CPP-115 Dose 3 | Other | 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. |
|
| CPP-115 Dose 4 | Other | 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. |
|
| CPP-115 Dose 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPP-115 | Drug | Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mardik Donikyan, DO | Clinilabs, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinilabs, Inc. | New York | New York | 10019 | United States |
Overnight fast prior to receiving dose
Phase 1 unit. Groups of 8 normal volunteer male subjects were screened & returned to unit evening before they were to receive their specified dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPP-115 Dose 1 | Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG001 | CPP-115 Dose 2 | Cohort 2a consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG002 | CPP-115 Dose 2 (Repeat) | Cohort 2(b) consisted of 7 subjects with 5 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG003 | CPP-115 Dose 3 | Cohort 3 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG004 | CPP-115 Dose 4 | Cohort 4 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG005 | CPP-115 Dose 5 | Cohort 5 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| FG006 | CPP-115 Dose 6 | Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects randomized to drug had plasma and urine levels of drug analyzed to produce pharmacokinetic profiles (e.g. time to maximum concentration (Cmax), half life (t1/2), area under the curve (AUC)
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| ID | Title | Description |
|---|---|---|
| BG000 | CPP-115 Dose 1 | Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Days 1-3, 8 & 30 |
|
30 days
Solicited and all events were considered treatment related. There were no SAEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Winship, Vice President of Regulatory Operations | Catalyst Pharmaceutical Partners, Inc. | 305 529-2522 | 12 | dwinship@catalystpharma.com |
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| ID | Term |
|---|---|
| C519726 | (1S,3S)-3-amino-4-difluoromethylenecyclopentanecarboxylic acid |
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| Other |
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. |
|
| CPP-115 Dose 6 | Other | 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. |
|
| Placebo | Drug | An equal volume of water mixed with juice will be administered. |
|
|
| BG001 | CPP-115 Dose 2 | Cohort 2a consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG002 | CPP-115 Dose 2 (Repeat) | Cohort 2(b) consisted of 7 subjects with 5 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG003 | CPP-115 Dose 3 | Cohort 3 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG004 | CPP-115 Dose 4 | Cohort 4 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG005 | CPP-115 Dose 5 | Cohort 5 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Progression to the next higher dose level was contingent upon demonstration of a satisfactory assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG006 | CPP-115 Dose 6 | Cohort 1 consisted of 8 subjects with 6 subjects randomized to receive CPP-115 and 2 subjects receiving matching placebo solution. Assessment of safety based on committee review the safety data obtained from this dose. Placebo : 5 ml water mixed with ~250 ml juice was administered. CPP-115 : Appropriate amount of drug substance dissolved in 5 ml water will be dissolved in ~250 ml juice within 3 hours of dosing. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CPP-115 Dose 2 (13mg) |
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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs |
| OG002 | CPP-115 Dose 3 (32mg) | 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. There were no deaths or SAEs CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. |
| OG003 | CPP-115 Dose 4 (80mg) | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs |
| OG004 | CPP-115 Dose 5 (200mg) | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs |
| OG005 | CPP-115 Dose 6 (500mg) | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs |
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| 0 |
| 6 |
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| 6 |
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| 6 |
| EG001 | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 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. There were no deaths or SAEs CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG003 | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | 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. CPP-115: Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing. Placebo: An equal volume of water mixed with juice will be administered. There were no deaths or SAEs | 0 | 6 | 0 | 6 | 1 | 6 |
| Infusion site pain | General disorders | Systematic Assessment |
|
| Blood CPK increased | Investigations | Systematic Assessment |
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| Groin | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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