Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

February 2, 2012 updated by: Catabasis Pharmaceuticals

A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

  • To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
  • To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
  • To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.

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.
52

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion Clinical Research Unit

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

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. In good health.
  2. Age: 19 to 55 years inclusive at Screening.

  3. Satisfies one of the following

    • Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
    • Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
  4. BMI: 18 to 30 kg/m2 at Screening.

Key Exclusion Criteria:

  1. Clinically significant abnormalities in physical examination or vital signs.
  2. Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
  3. Clinically significant screening laboratory result as assessed by the Investigator.
  4. The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  5. History or presence of malignancy with the past 5 years.
  6. History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
  7. Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
  8. Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
  9. Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
  10. A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
  11. Any clinically significant systemic infection within 3 weeks prior to screening.
  12. Use of prescription medications within 30 days of screening.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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.
Experimental: Cohort 1 / Dose level 1
Single dose orally: CAT-1004 Dose level 1 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 2 / Dose level 2
Single dose orally: CAT-1004 Dose level 2 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 3 /Dose level 3
Single dose orally: CAT-1004 Dose level 3 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 4/ Dose level 4
Single dose orally: CAT-1004 Dose level 4 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 5/ Dose level 5
Single dose orally: CAT-1004 Dose level 5 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 2/ Dose level 2 ( FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 3/ Dose level 3 (FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 6 / Dose level 6 (FE)
Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
Experimental: Cohort 7 / Dose level 7 (FE)
Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.
Drug: Drug
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
  • CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

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
Time Frame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.
Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Profile
Time Frame: Plasma blood samples through 72 hrs, urine collections through 48 hrs
The following noncompartmental PK parameters will be calculated: area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), area under concentration-time curve from time 0 to time of last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), terminal phase elimination half-life (t½), apparent oral clearance (CL/F), and volume of distribution during the terminal phase (Vz/F). Additional PK parameters may be calculated if deemed appropriate.
Plasma blood samples through 72 hrs, urine collections through 48 hrs

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.
Catabasis Pharmaceuticals

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.
September 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.
January 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.
January 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).
September 8, 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.
September 23, 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.
September 26, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
February 6, 2012

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.
February 2, 2012

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.
February 1, 2012

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.
  • CAT-1004-101

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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