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Clinical Trial Details

Trial ID: L2127
Source ID: NCT02862431
Associated Drug: Jnj-64565111
Title: Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: JNJ-64565111|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability, Up to Day 72 | Secondary: Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity, Up to Day 72|Change From Baseline in Body Weight, Baseline, up to Day 72|Maximum Observed Plasma Concentration (Cmax), Maximum observed plasma concentration (Cmax) will be assessed after first dose and last dose., Up to Day 72|Time to Reach Maximum Observed Plasma Concentration (Tmax), Tmax defined as actual sampling time to reach maximum observed analyte concentration will be assessed after first dose and last dose., Up to Day 72|Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last), AUC from time zero to the last quantifiable concentration will be assessed after first dose and after last dose., Up to Day 72|Area Under Curve over the dosing interval AUC(0-tau), The AUC \[0-tau\] is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. AUC \[0-tau\] will be assessed after first dose and last dose., Up to Day 72|Elimination Half-Life (t1/2), The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. t1/2 will be assessed after first dose and last dose., Up to Day 72|Apparent Clearance (CL/F), The Oral Clearance (CL/F) is the clearance based on oral bioavailability. CL/F will be assessed after first dose and last dose., Up to Day 72|Apparent Volume of Distribution (V/F), Apparent volume of distribution will be assessed after first dose and last dose., Up to Day 72|Terminal Rate Constant (K), Terminal rate constant will be assessed after first dose and last dose., Up to Day 72|Average concentration over the dosing interval at steady state (Caverage,ss), The average concentration over the dosing interval at steady state, calculated as AUC(0-tau)/tau and will be assessed after last dose., Up to Day 72|Minimum Observed Plasma Concentration (Cmin), The Cmin is the minimum observed plasma concentration over the dosing interval at steady state. Cmin will be assessed after last dose., Up to Day 72|Area Under Curve from time zero extrapolated to infinity AUC(0-inf), AUC from time zero extrapolated to infinity will be assessed after last dose., Up to Day 72|Accumulation Ratio, Accumulation ratio calculated as AUC(0-tau), Day 22 / AUC(0-tau), Day 1 will be assessed after last dose., Up to Day 72|Change From Baseline in Blood Pressure, Baseline, up to Day 72|Change From Baseline in Heart Rate, Baseline, up to Day 72|Change From Baseline for 24-hour Mean Plasma Glucose, Mean plasma glucose defined as the total and/or incremental area under the concentration (AUC) time curve over 0 to 24 hours, divided by 24., Baseline, Day 26|Change From Baseline in Fasting Plasma Glucose (FPG), Baseline, up to Day 72|Change From Baseline in Hemoglobin A1c (HbA1c), Baseline, up to Day 72|Change From Baseline on Fasting Lipids, Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglycerides and free fatty acids will be reported., Baseline, up to Day 72|Change From Baseline in Insulin Secretion, Baseline, Day 26|Change From Baseline in Insulin Sensitivity, Baseline, Day 26|Change From Baseline for C-peptide, Baseline, Day 26|Change From Baseline for Glucagon, Baseline, Day 26
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-07-12
Completion Date: 2016-12-05
Results First Posted:
Last Update Posted: 2025-04-01
Locations: Neuss, Germany
URL: https://clinicaltrials.gov/show/NCT02862431