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A Safety, Tolerability and Pharmacokinetic Study of CPP-115

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01493596
Enrollment
55
Registered
2011-12-16
Start date
2011-12-31
Completion date
2012-08-31
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependency

Keywords

Safety, Tolerability

Brief 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

Interventions

DRUGCPP-115

Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.

DRUGPlacebo

An equal volume of water mixed with juice will be administered.

Sponsors

Catalyst Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety of Single Oral DosesDays 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.

Countries

United States

Participant flow

Recruitment details

Phase 1 unit. Groups of 8 normal volunteer male subjects were screened & returned to unit evening before they were to receive their specified dose.

Pre-assignment details

Overnight fast prior to receiving dose

Participants by arm

ArmCount
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.
6
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.
6
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.
5
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.
6
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.
6
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.
6
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.
6
Total41

Baseline characteristics

CharacteristicCPP-115 Dose 2CPP-115 Dose 2 (Repeat)CPP-115 Dose 3CPP-115 Dose 4CPP-115 Dose 1CPP-115 Dose 5CPP-115 Dose 6Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants5 Participants6 Participants6 Participants6 Participants6 Participants6 Participants41 Participants
Age, Continuous32.6 years
STANDARD_DEVIATION 5.67
35.2 years
STANDARD_DEVIATION 12.11
38.8 years
STANDARD_DEVIATION 4.83
40.8 years
STANDARD_DEVIATION 9.93
35.8 years
STANDARD_DEVIATION 13.01
38.0 years
STANDARD_DEVIATION 10.6
35.5 years
STANDARD_DEVIATION 7.5
36.8 years
STANDARD_DEVIATION 9.09
Region of Enrollment
United States
6 participants5 participants6 participants6 participants6 participants6 participants6 participants41 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
6 Participants5 Participants6 Participants6 Participants6 Participants6 Participants6 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 50 / 60 / 60 / 6
other
Total, other adverse events
0 / 61 / 61 / 50 / 61 / 61 / 6
serious
Total, serious adverse events
0 / 60 / 60 / 50 / 60 / 60 / 6

Outcome results

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.

Time frame: Days 1-3, 8 & 30

ArmMeasureValue (NUMBER)
CPP-115 Dose 1 (5mg)Safety of Single Oral Doses0 participants
CPP-115 Dose 2 (13mg)Safety of Single Oral Doses0 participants
CPP-115 Dose 3 (32mg)Safety of Single Oral Doses0 participants
CPP-115 Dose 4 (80mg)Safety of Single Oral Doses0 participants
CPP-115 Dose 5 (200mg)Safety of Single Oral Doses0 participants
CPP-115 Dose 6 (500mg)Safety of Single Oral Doses0 participants
Comparison: Descriptive statistics for evaluation of AEs

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026