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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01440166
First received: September 8, 2011
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose
  • 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.

Condition Intervention Phase
Healthy
 Drug: Drug
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU ] [ Designated as safety issue: Yes ]
    Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.


Secondary Outcome Measures:
  • Pharmacokinetic Profile [ Time Frame: Plasma blood samples through 72 hrs, urine collections through 48 hrs ] [ Designated as safety issue: No ]
    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.
Enrollment: 52
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CAT-1004
Other: Placebo
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

  Eligibility
Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440166

Locations
United States, Nebraska
Celerion Clinical Research Unit
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Catabasis Pharmaceuticals
Investigators
Principal Investigator: Scott Rasmussen, MD Celerion
  More Information

No publications provided

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01440166     History of Changes
Other Study ID Numbers: CAT-1004-101
Study First Received: September 8, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Catabasis Pharmaceuticals:
Human healthy volunteers

ClinicalTrials.gov processed this record on March 03, 2015