NCT00882726

A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus

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, Pharmacodynamics, and Immune Response of CNTO 3649

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician nor patient knows the name of the assigned study medication), ascending-dose 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 approximately 80 healthy participants (Part 1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48 participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an intravenous infusion (directly into a vein) and 32 participants will receive single doses of CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36 diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy participants and diabetes patients, respectively. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	CNTO 3649 IV (Healthy participants)	Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.
DRUG	CNTO 3649 SC (Healthy participants)	Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.
DRUG	CNTO 3649 SC (Diabetic patients)	Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.
DRUG	Placebo	Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-04-16
• Last updated: 2013-12-16

Locations

3 sites across 1 country: United States