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

NCT ID: NCT01511900

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: Dose level 1

Multiple dose orally: CAT-1004 Dose level 1 or placebo

Group Type: EXPERIMENTAL

CAT 1004

Intervention Type: DRUG

Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004

Placebo

Intervention Type: DRUG

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

Cohort 2: Dose level 2

Multiple dose orally: CAT-1004 Dose level 2 or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

CAT 1004

Intervention Type: DRUG

Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004

Cohort 3: Dose level 3

Multiple dose orally: CAT-1004 Dose level 3 or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

CAT 1004

Intervention Type: DRUG

Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004

Cohort 4: Dose level 4

Multiple dose orally: CAT-1004 Dose level 4 or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

CAT 1004

Intervention Type: DRUG

Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004

Cohort 5: Dose level TBD

Multiple dose orally: CAT-1004 Dose level TBD or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

CAT 1004

Intervention Type: DRUG

Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004

Interventions

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

Intervention Type: DRUG

Placebo

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catabasis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanne Donovan, M.D., PhD

Role: STUDY_DIRECTOR

Catabasis

Locations

Chula Vista, California, United States

Countries

United States

Other Identifiers

CAT 1004 102

Identifier Type: -

Identifier Source: org_study_id