Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64565111 · 4 trials · 4 indications
Placebo-corrected change from baseline in QT interval corrected for individual heart rate (QTcI) on day 26 time-matched time points will be determined. The mean change from baseline in QTcI for participants who receive placebo will be subtracted from the mean change from baseline in QTcI for participants on JNJ-64565111 at the same time point to generate placebo-corrected change from baseline in QTcI, which will be presented.
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
The HR will be measured by ECG.
The QRS Intervals will be measured by ECG.
The PR intervals will be measured by ECG.
Cmax is the maximum observed serum analyte concentration.
AUC \[0-infinity) is the area under the serum concentration versus time curve from time 0 to infinite time, calculated as AUClast + Clast/lambda(z) where Clast is the last observed measurable (non- below quantification limit \[BQL\]) concentration.
AUC (0-last) is the area under the serum concentration versus time curve from time 0 to time of the last measurable (non-below quantification limit \[BQL\]) concentration, calculated by linear linear trapezoidal summation.
Number of participants with gastrointestinal adverse events will be assessed. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Cmax is the maximum observed serum analyte concentration of JNJ-64565111.
AUC \[0-Last\] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation.
AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1: JNJ-64565111+Moxifloxacin Placebo | EXPERIMENTAL | Participant will receive JNJ-64565111 on days 2, 9, 16, and 23 and moxifloxacin-matching placebo on days 1 and 27. |
| Treatment Group 2: JNJ-64565111 Matching Placebo+Moxifloxacin | ACTIVE_COMPARATOR | Participant will receive JNJ-64565111-matching placebo on days 2, 9, 16, and 23. Participants will also receive moxifloxacin on day 1 and moxifloxacin-matching placebo on day 27 (sequence 2a) or moxifloxacin-matching placebo on day 1 and moxifloxacin on day 27 (sequence 2b) in a nested crossover manner. |
| Part A: Treatment Sequence ABC: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment A (JNJ-64565111 subcutaneous \[SC\] administration in the upper arm in fasted condition) on Day 1 of Treatment Period 1; followed by Treatment B (JNJ-64565111 SC administration in the thigh in fasted condition) on Day 1 of Treatment Period 2 and then Treatment C (JNJ-64565111 SC administration in the abdomen in fasted condition) on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last pharmacokinetic (PK) sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence ACB: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment A on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence BAC: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment C on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence BCA: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence CAB: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence CBA: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment B on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part B: JNJ-64565111 | EXPERIMENTAL | Participants will receive a single SC ascending doses of JNJ-64565111 on Days 1, 8, 15, 22, 29 and 36. |
| Group 1: JNJ-64565111 | EXPERIMENTAL | Participants with normal renal function and no evidence of kidney damage (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter/minute \[mL/min\]) will be enrolled. Participants will receive a single subcutaneous (SC) dose of JNJ-64565111 on Day 1. |
| Group 2: JNJ-64565111 | EXPERIMENTAL | Participants with mild renal impairment (eGFR 60 to less than \[\<\] 90 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 3: JNJ-64565111 | EXPERIMENTAL | Participants with moderate renal impairment (eGFR 30 to \<60 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 4: JNJ-64565111 | EXPERIMENTAL | Participants with severe renal impairment (eGFR \<30 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 5: JNJ-64565111 | EXPERIMENTAL | Participants with end-stage renal disease (requiring hemodialysis 3 times per week for at least 3 months before screening; eGFR will not be calculated) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Cohort 1 to 4: JNJ-64565111 or Placebo | EXPERIMENTAL | Participants in cohort 1 to 4 in a ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22. Cohort 1, 2 and 3 will be dosed in parallel. Dosing for subsequent cohort 4 will be escalated based on review by the Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29, but will not exceed from well-tolerated dose. |
| Cohort 5: JNJ-64565111 (Repeat or Lower Dose) or Placebo | EXPERIMENTAL | Participants in ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22, and may be modified. The dose can be repeated or lower than a dose previously assessed as well tolerated. |
| Name | Type | Description |
|---|---|---|
| JNJ-64565111 | DRUG | Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23. |
| Moxifloxacin | DRUG | Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner. |
| JNJ-64565111-matching Placebo | DRUG | Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23. |
| Moxifloxacin-matching Placebo | DRUG | Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2. |
| Placebo | DRUG | Participants will receive placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22. |
Inclusion Criteria: * Body mass index (BMI) between 25.0 and 40.0 kilogram per square meter ( kg/m\^2), inclusive, and a body weight of not less than 80 kg * Blood pressure (BP) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic * If a woman, m...
JNJ-64565111 is an investigational small molecule being studied for metabolic conditions including obesity, type 2 diabetes mellitus, and chronic kidney failure. It has been evaluated in Phase 1 clinical trials in healthy volunteers and in patients with these conditions. The drug is not approved and remains in early clinical development.
JNJ-64565111 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 1 clinical development for metabolic indications including obesity and type 2 diabetes.
JNJ-64565111 is in Phase 1 clinical development. All four completed trials for this drug were Phase 1 studies. It is an investigational agent and has not been approved by regulatory authorities. The studies assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in various participant populations.
JNJ-64565111 has been studied in four completed Phase 1 trials. NCT03235219 assessed multiple doses in type 2 diabetes patients. NCT03546205 evaluated pharmacokinetics in participants with varying renal function. NCT03586843 studied administration at different injection sites in overweight and obese adults. NCT03606057 examined effects on cardiac repolarization in healthy adults.
No, JNJ-64565111 is not the same as JNJ-6456511. The clinical trial NCT03586843 lists JNJ-64565111 in its title but references JNJ-6456511 in the study description. These appear to be distinct identifiers for the drug candidate, though the relationship between the two names is not specified.