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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00882726 |
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: CNTO 3649; Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmaco |
Estimated Enrollment: | 116 |
Study Start Date: | February 2009 |
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or patient knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of 80 healthy participants and 36 type 2 diabetic patients. Six dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits.
Placebo (containing inactive substances only) or one of six dose levels of CNTO 3649 will be given. Healthy subjects will be given a single IV infusion (directly into a vein) or a single dose of up to 2 injections under the skin. Diabetic patients will be given 4 doses as up to 2 injections under the skin (SC) over 4 weeks. There will be a screening period of up to 30 days. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
United States, Florida | |
Recruiting | |
Miramar, Florida, United States, 33025 |
Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Study ID Numbers: | CR015562 |
Study First Received: | April 14, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00882726 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Type 2 Diabetes Mellitus CNTO 3649 Phase I healthy adults safety |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |