Trial Outcomes & Findings for A Safety, Tolerability and Pharmacokinetic Study of CPP-115 (NCT NCT01493596)
NCT ID: NCT01493596
Last Updated: 2021-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
Days 1-3, 8 & 30
Results posted on
2021-04-20
Participant Flow
Phase 1 unit. Groups of 8 normal volunteer male subjects were screened \& returned to unit evening before they were to receive their specified dose.
Overnight fast prior to receiving dose
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
Baseline characteristics by cohort
| Measure |
CPP-115 Dose 1
n=6 Participants
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.
|
CPP-115 Dose 2
n=6 Participants
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.
|
CPP-115 Dose 2 (Repeat)
n=5 Participants
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.
|
CPP-115 Dose 3
n=6 Participants
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.
|
CPP-115 Dose 4
n=6 Participants
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.
|
CPP-115 Dose 5
n=6 Participants
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.
|
CPP-115 Dose 6
n=6 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
41 Participants
n=6 Participants
|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 13.01 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 5.67 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 4.83 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 9.93 • n=21 Participants
|
38.0 years
STANDARD_DEVIATION 10.6 • n=10 Participants
|
35.5 years
STANDARD_DEVIATION 7.5 • n=115 Participants
|
36.8 years
STANDARD_DEVIATION 9.09 • n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
41 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
41 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Days 1-3, 8 & 30Number 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.
Outcome measures
| Measure |
CPP-115 Dose 1 (5mg)
n=6 Participants
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
|
CPP-115 Dose 2 (13mg)
n=6 Participants
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
|
CPP-115 Dose 3 (32mg)
n=5 Participants
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.
|
CPP-115 Dose 4 (80mg)
n=6 Participants
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
|
CPP-115 Dose 5 (200mg)
n=6 Participants
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
|
CPP-115 Dose 6 (500mg)
n=6 Participants
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
|
|---|---|---|---|---|---|---|
|
Safety of Single Oral Doses
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
CPP-115 Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CPP-115 Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CPP-115 Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CPP-115 Dose 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CPP-115 Dose 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CPP-115 Dose 6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPP-115 Dose 1
n=6 participants at risk
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
|
CPP-115 Dose 2
n=6 participants at risk
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
|
CPP-115 Dose 3
n=5 participants at risk
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.
|
CPP-115 Dose 4
n=6 participants at risk
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
|
CPP-115 Dose 5
n=6 participants at risk
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
|
CPP-115 Dose 6
n=6 participants at risk
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
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
20.0%
1/5 • Number of events 1 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
|
General disorders
Infusion site pain
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/5 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
16.7%
1/6 • Number of events 1 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
|
Investigations
Blood CPK increased
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
16.7%
1/6 • Number of events 1 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/5 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
16.7%
1/6 • Number of events 1 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
|
Musculoskeletal and connective tissue disorders
Groin
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/5 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
16.7%
1/6 • Number of events 1 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
0.00%
0/6 • 30 days
Solicited and all events were considered treatment related. There were no SAEs.
|
Additional Information
Douglas Winship, Vice President of Regulatory Operations
Catalyst Pharmaceutical Partners, Inc.
Phone: 305 529-2522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60