A Safety, Tolerability and Pharmacokinetic Study of CPP-115

March 25, 2021 updated by: Catalyst Pharmaceuticals, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Clinilabs, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115
OTHER: 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.
Drug: CPP-115
Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
Drug: Placebo
An equal volume of water mixed with juice will be administered.
Other Names:
  • CPP-115

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of Single Oral Doses
Time Frame: Days 1-3, 8 & 30
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catalyst Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mardik Donikyan, DO, Clinilabs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPP-115-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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