Safety, Pharmacokinetics, and Pharmacodynamics Study of Single Dose of CNTO 3649 in Healthy Adult Men and Multiple Doses of CNTO 3649 in Participants With Type 2 Diabetes Mellitus
Condition: Healthy; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety (adverse events, weight, blood
      pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead
      electrocardiography, and laboratory tests) of CNTO 3649 when administered once by
      subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese
      participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in
      the body or the body's insulin is not effective, resulting in high blood sugar, increased
      thirst and urine, and many other side effects).
    

Detailed description: 
      This is a Phase 1, multi-arm and open-label (all knew the intervention of study) study to
      explore the safety, pharmacodynamics (the study of how drugs act on the body) and
      pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over
      time) of CNTO 3649. The study has been divided in Part 1 and 2. Part 1 includes healthy adult
      Japanese men and Part 2 includes Japanese participants with type 2 diabetes mellitus. The
      healthy adult Japanese men in part 1 will receive a single dose of either 10, 30, 100 or 300
      microgram/milliliter (mcg/mL) of CNTO 3649 and participants in part 2 will receive
      subcutaneous doses of either 30 or 100 mcg/mL of CNTO 3649 once a week for 4 weeks. The study
      will have a Screening period of 28 days for Part 1 and 42 days for Part 2. Participants will
      primarily be assessed for safety (adverse events, weight, blood pressure, pulse rate, body
      temperature, abdominal ultrasonography, standard 12-lead electrocardiography, and laboratory
      test). The total duration of study will be 57 days for Part 1 and 92 days for Part 2.
    

Intervention name(s): CNTO 3649 10 mcg/kg; CNT0 3649 30 mcg/kg; CNTO 3649 100 mcg/kg; CNTO 3649 300 mcg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.; A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 30 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.; A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 100 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.; A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.; Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Diabetes Mellitus, Type 2; CNTO 3649