NCT02224118

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

Safety, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Dose of CNTO 3649 in Healthy Adult Men and Multiple Subcutaneous Doses of CNTO 3649 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	CNTO 3649 10 mcg/kg	A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.
DRUG	CNT0 3649 30 mcg/kg	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.
DRUG	CNTO 3649 100 mcg/kg	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.
DRUG	CNTO 3649 300 mcg/kg	A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.
DRUG	Placebo	Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2014-08-25
• Last updated: 2014-09-09

Locations

1 site across 1 country: Japan