A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01511900
First received: January 8, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).

Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients with T2D.


Condition Intervention Phase
Type 2 Diabetes
Drug: CAT 1004
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAT-1004 in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Screening to Follow-up (Day 25) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUCinf of CAT-1004 [ Time Frame: Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4 [ Time Frame: Day -2 through f/u (Day 25) ] [ Designated as safety issue: No ]
  • Cmax of CAT-1004 [ Time Frame: Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Changes from baseline for hematology, chemistry, coagulation and urinalysis [ Time Frame: Baseline through End of study (Day 25) ] [ Designated as safety issue: Yes ]
  • Changes from baseline for Physical exams [ Time Frame: Baseline through end of study (Day 25) ] [ Designated as safety issue: Yes ]
  • Changes from baseline for ECGs [ Time Frame: Baseline through end of study (Day 25) ] [ Designated as safety issue: Yes ]
  • Changes from baseline in vital signs [ Time Frame: Baseline through end of study (Day 25) ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Dose level 1
Multiple dose orally: CAT-1004 Dose level 1 or placebo
Drug: CAT 1004
Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004
Drug: Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
Experimental: Cohort 2: Dose level 2
Multiple dose orally: CAT-1004 Dose level 2 or placebo
Drug: Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
Drug: CAT 1004
Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004
Experimental: Cohort 3: Dose level 3
Multiple dose orally: CAT-1004 Dose level 3 or placebo
Drug: Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
Drug: CAT 1004
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004
Experimental: Cohort 4: Dose level 4
Multiple dose orally: CAT-1004 Dose level 4 or placebo
Drug: Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
Drug: CAT 1004
Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004
Experimental: Cohort 5: Dose level TBD
Multiple dose orally: CAT-1004 Dose level TBD or placebo
Drug: Placebo
Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
Drug: CAT 1004
Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient must meet all of the following criteria to be in the study:

  • Age between 18 to 65 years inclusive at Screening.
  • Diagnosis of T2D:
  • For Part I:

    • Treated with any diet and exercise, with or without metformin (stable for ≥ 2 months).
    • HbA1c ≥ 7.0% and ≤ 10.0% if on diet and exercise alone, or ≥6.5 % and ≤ 9.0% if on metformin.
  • For Part II:

    • Stable on metformin for ≥ 2 months with HbA1c ≥ 7.0% and ≤ 10.0%.

  • Satisfies one of the following:

    • Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR
    • Males: surgically sterile, abstinent, or patient or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
  • On a stable diet with body mass index (BMI): 25 to 40 kg/m2 inclusive at Screening with weight stable (± 4 kg) for > 6 weeks prior to Screening.

Exclusion Criteria:

A patient will not be eligible if any of the following criteria apply:

  • Use of prescription medications other than allowed medications within 30 days of planned admission to the clinic. Allowed medications include metformin, anti-hypertensives, lipid-lowering medications, thyroid replacement therapy, low-dose aspirin (81 mg/day), proton pump inhibitors and anti-depressants. Prescribed doses of these medications must have been stable for 2 months at the time of first dose.
  • Clinically significant abnormalities in physical examination or vital signs at screening
  • Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
  • Clinically significant laboratory result as assessed by the Investigator.
  • The patient has a history of clinically significant medical disease including significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease, other than T2D, hypertension, dyslipidemia, hypothyroidism or depression.
  • History or presence of malignancy within the past 5 years.
  • History of Type 1 diabetes or clinically significant cardiovascular disease (including a history of unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, or New York Heart Association Class III or IV congestive heart failure within 6 months prior to screening) or clinically significant renal disease.
  • 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 or 5 half-lives of the study agent, whichever is longer.
  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: NCT01511900

Locations
United States, California
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Catabasis Pharmaceuticals
Investigators
Study Director: Joanne Donovan, M.D., PhD Catabasis
  More Information

No publications provided

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01511900     History of Changes
Other Study ID Numbers: CAT 1004 102
Study First Received: January 8, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014