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

NCT01511900 | Completed Phase 1

• 1 other identifier: CAT 1004 102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events

  Screening to Follow-up (Day 25)

Secondary Outcomes (7)

• AUCinf of CAT-1004

  Days 1, 7 and 14

• Glucose area under the curve for 0-24 hrs/24 and 0-4 hrs/4

  Day -2 through f/u (Day 25)

• Cmax of CAT-1004

  Days 1, 7 and 14

• Changes from baseline for hematology, chemistry, coagulation and urinalysis

  Baseline through End of study (Day 25)

• Changes from baseline for Physical exams

  Baseline through end of study (Day 25)

Study Arms (5)

Cohort 1: Dose level 1

EXPERIMENTAL

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

Drug: CAT 1004; Drug: Placebo

Cohort 2: Dose level 2

EXPERIMENTAL

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

Drug: Placebo; Drug: CAT 1004

Cohort 3: Dose level 3

EXPERIMENTAL

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

Drug: Placebo; Drug: CAT 1004

Cohort 4: Dose level 4

EXPERIMENTAL

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

Drug: Placebo; Drug: CAT 1004

Cohort 5: Dose level TBD

EXPERIMENTAL

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

Drug: Placebo; Drug: CAT 1004

Interventions

CAT 1004 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

Cohort 1: Dose level 1

Placebo DRUG

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

Cohort 1: Dose level 1; Cohort 2: Dose level 2; Cohort 3: Dose level 3; Cohort 4: Dose level 4; Cohort 5: Dose level TBD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catabasis Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joanne Donovan, M.D., PhD

  Catabasis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: January 19, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

US (1)