Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03607513 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Participants | PHASE1 | COMPLETED | 105 | — | — | Jul 31, 2018 | Aug 9, 2019 | Feb 3, 2025 | 1 | Belgium |
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.
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.
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Tmax is defined as actual sampling time to reach maximum observed concentration.
Tmax is defined as actual sampling time to reach maximum observed concentration.
The Tlast is the time to last observed quantifiable plasma concentration.
The Tlast is the time to last observed quantifiable plasma concentration.
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
AUClast is defined as area under the plasma JNJ-64264681 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
AUCtau is area under the plasma JNJ-64264681 concentration-time curve during a dosing interval (tau) at steady-state.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
MAD: Accumulation Ratio obtained by dividing AUC of JNJ-64264681 at two different time points.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD) | EXPERIMENTAL | The SAD part will consist of 6 escalating dose cohorts and 1 fed cohort of healthy male participants, 2 dose escalating cohorts of healthy female participants, and 1 solid dose formulation (capsule) cohort of healthy male participants, who will be dosed after completion of the dose escalation cohorts. Participants in each cohort (except for the solid dose formulation cohort) will receive JNJ-64264681 or Placebo on Day 1, orally. In the solid dose formulation cohort, participants will receive JNJ-64264681 capsule on Day 1. Doses for the female cohorts and fed cohort will be selected based on safety, tolerability, pharmacokinetics (PK),and pharmacodynamic (PD) data from preceding cohorts and the dose for the solid dose formulation cohort will be selected and approximately equal to a dose previously studied in the single ascending dose cohorts. |
| Multiple Ascending Dose (MAD) | EXPERIMENTAL | The MAD part will consist of 3 dose escalation cohorts of males and females. Participants will receive once-daily oral doses of JNJ-64264681 or placebo for 10 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-64264681 | DRUG | For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration. |
| Placebo | DRUG | Matching placebo to JNJ-64264681 will be administered as oral solution. |
Inclusion Criteria: * Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2) (BMI = weight\[kg\]/height\[m\]\^2), and a body weight of not less than 50 kilogram (kg) * Participant must be healthy on the basis of physical examination, medical history,...