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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03439488 | A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B | PHASE1 | COMPLETED | 130 | — | — | Mar 26, 2018 | Oct 10, 2019 | Feb 3, 2025 | 7 | Moldova, New Zealand +3 |
Number of participants with AE (any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be reported.
A symptom directed physical examination (including body weight measurement and skin examination) will be performed to further assess number of participants with clinically significant changes.
Number of participants with clinically significant changes in the vital signs will be reported.
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Number of participants with Holter monitoring abnormalities will be reported.
Number of participants with clinical laboratory abnormalities will be reported.
The Cmax is the maximum observed plasma concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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.
The Cmax is the maximum observed plasma concentration.
C(0-tau) is defined as the observed plasma concentration from time 0 to tau hours postdose (tau = dosing interval).
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Healthy Participants): Single Ascending Dose (SAD) | EXPERIMENTAL | Participants in Cohorts 1 to 5 and 3 optional cohorts (Cohorts 6, 7 and 10) will receive a single dose of JNJ-440/placebo on Day 1. Two cohorts will receive a second dose of JNJ-440/placebo in a fed state (participants from Cohort 3 will also participate in Cohort 8) or as an alternative JNJ-440 formulation (participants from Cohort 2 will also participate in optional Cohort 9) after a washout window of at least 10 days. In Cohorts 1 to 4, study drug will be administered under fasted conditions; in the remaining cohorts, study drug will be administered under fasted/fed conditions depending on the results of the food effect evaluation. |
| Part 2 (Healthy Participants): Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants in Cohorts 1 and 2 will receive a once daily dose of JNJ-440/placebo for the duration of 7 days under fasted or fed conditions. Participants in an optional cohort (Cohort 3) may receive a once daily or twice daily dose of JNJ-440/placebo for the duration of 7 or 14 days under fasted or fed conditions. The starting dose for Cohort 1 in Part 2 will be determined by the Sponsor in consultation with the Principal Investigator based on the data from Part 1. Dose escalation will be performed only after review of safety and pharmacokinetic (PK) data after a minimum of 7 days of study drug administration. |
| Part 3 (Chronic Hepatitis B [CHB] Participants): MAD | EXPERIMENTAL | Participants in Cohorts 1 and 2 and 3 optional cohorts (Cohorts 3, 4, and 5) will receive multiple ascending doses of JNJ-440/placebo once daily or twice daily for 28 days under fed or fasted conditions. The starting dose and formulation for Cohort 1 will be determined based on the review of available data in healthy participants from Part 1 (SAD) and Part 2 (MAD). Dose escalation will be performed only after review of safety, tolerability, and PK data after a minimum of 14 days of study drug administration from at least 8 CHB participants. |
| Name | Type | Description |
|---|---|---|
| JNJ-440 | DRUG | JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1. |
| Placebo | DRUG | Matching placebo as oral tablets will be administered in Parts 1, 2 and 3. |
Inclusion Criteria: Inclusion Criteria for Healthy Participants: * Female participants (except for postmenopausal women) must have a negative pregnancy test at screening and on Day -1 * Participants must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in mete...