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Clinical Trial Details

Trial ID: L4478
Source ID: NCT02224118
Associated Drug: Cnto 3649 10 Mcg/Kg
Title: 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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy|Diabetes Mellitus, Type 2
Interventions: DRUG: CNTO 3649 10 mcg/kg|DRUG: CNT0 3649 30 mcg/kg|DRUG: CNTO 3649 100 mcg/kg|DRUG: CNTO 3649 300 mcg/kg|DRUG: Placebo
Outcome Measures: Primary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 57 for CNTO 3649 10, 30, 100 and 300 microgram per kilogram (mcg/kg) (Part 1); Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2) that would be absent before treatment or that may worsen relative to pre-treatment state., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2) | Secondary: Maximum Observed Serum Concentration (Cmax), Maximum Observed Serum Concentration (Cmax) will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Time to Reach Maximum Observed Serum Concentration (Tmax), Time to Reach Maximum Observed Serum Concentration (Tmax) will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Terminal Phase Elimination Half Life (t1/2), Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - last]), Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC\[0 - last\]) will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - infinity]), Area Under the Concentration-time Curve From Zero to Infinity (AUC \[0 - infinity\]) will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Apparent Systemic Clearance (CL/F), Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability)., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Apparent Volume of Distribution (Vz/F), Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Mean Percentage Change From Baseline in Blood Glucose Values, Serum Insulin Concentration, and Serum C-Peptide Concentration, Mean percentage change from baseline in blood glucose values, serum insulin concentration, and serum c-peptide concentration will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)|Weighted Average Blood Glucose (WAG) Level, The WAG level is calculated as: WAG = Area under concentration (AUC) 24 /24 hours) the day before the first injection and on treatment Day 24 for CNTO 3649 30 or 100 mcg/kg for part 2 participants., Day -1 (Predose) and 24|Change From Baseline in Glycosylated Haemoglobin (Hb) A1c at Day 36 and 50, Change From Baseline in Glycosylated Haemoglobin (Hb) A1c at Day 36 and 50 will be observed., Baseline, Day 36 and 50|Number of Participants Exhibiting Anti-Drug Antibodies for CNTO 3649 at any Visit, Number of participants exhibiting anti-drug antibodies for CNTO 3649 will be observed., Day 1 to 57 for CNTO 3649 10, 30, 100 and 300 mcg/kg (Part 1) or Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2)
Sponsor/Collaborators: Sponsor: Janssen Pharmaceutical K.K.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-07
Completion Date: 2010-03
Results First Posted:
Last Update Posted: 2014-09-09
Locations: Fukukoka, Japan
URL: https://clinicaltrials.gov/show/NCT02224118