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| ID | Type | Description | Link |
|---|---|---|---|
| 64565111EDI1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-001084-37 | EudraCT Number |
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The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo) | Experimental | Participants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo. |
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| Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo) | Experimental | Participants in ratio of 3:1 will receive 3.0 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg. |
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| Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo) | Experimental | Participants in ratio of 3:1 will receive 3.5 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg. |
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| Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo) | Experimental | Participants in ratio of 3:1 will receive a dose of JNJ-64565111 or placebo that would be a repeat or lower dose level previously assessed as well-tolerated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64565111 | Drug | Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 72 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuss | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22. |
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| 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 |
| D004700 | Endocrine System Diseases |