- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440166
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
Study Type
Interventional
Enrollment (Actual)
52
Phase
- 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
-
-
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
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- In good health.
- Age: 19 to 55 years inclusive at Screening.
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.
- BMI: 18 to 30 kg/m2 at Screening.
Key Exclusion Criteria:
- Clinically significant abnormalities in physical examination or vital signs.
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant screening laboratory result as assessed by the Investigator.
- 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.
- History or presence of malignancy with the past 5 years.
- 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).
- 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.
- Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
- 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.
- A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
- Any clinically significant systemic infection within 3 weeks prior to screening.
- 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 |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 / Dose level 1
Single dose orally: CAT-1004 Dose level 1 or placebo
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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.
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
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.
|
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
Other Names:
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
September 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 23, 2011
First Posted (Estimate)
September 26, 2011
Study Record Updates
Last Update Posted (Estimate)
February 6, 2012
Last Update Submitted That Met QC Criteria
February 2, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID 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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