Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-64041575 (oral suspension formulation), JNJ-64041575 (oral tablet formulation ), Lumicitabine, JNJ-64041575
ALS-008176 · 3 trials · 2 indications
Percentage of participants with asthma diagnosed by physician were reported.
Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\*100.
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 the time of the last measurable concentration.
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 of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
The Tmax is the time to reach the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Time of last measurable (non-below quantification limit \[non-BQL\]) plasma concentration.
The AUC (0-last) is the area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable concentration, calculated by linear-linear trapezoidal summation.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.
The %AUC\[infinity,ex\] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].
The Lambda (alpha) determined by linear regression of the first elimination phase of the ln-linear plasma concentration-time curve.
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
The t(1/2alpha) is defined as 0.693/Lambda (alpha).
The t(1/2term) is defined as 0.693/Lambda (z).
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together {Ae\[0-48hours(h)\]}.
Total percentage of the dose excreted into urine, calculated as 100 \* (Ae\[total\]/Dose).
Renal clearance calculated as Ae (0-48h)/AUC (0-48h).
| Arm | Type | Description |
|---|---|---|
| Lumicitabine | EXPERIMENTAL | Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage. |
| Placebo | PLACEBO_COMPARATOR | Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage. |
| Group 1: Participants With Normal Renal Function | EXPERIMENTAL | Adult participants with normal renal function (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter per minute \[mL/min\]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 2: Participants With Mild Renal Impairment | EXPERIMENTAL | Adult participants with mild impaired renal function (eGFR \>=60 to less than \[\<\] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 3: Participants With Moderate Renal Impairment | EXPERIMENTAL | Adult participants with moderate impaired renal function (eGFR \>=30 to \<60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 4: Participants With Severe Renal Impairment | EXPERIMENTAL | Adult participants with severe impaired renal function (eGFR \>= 15 to \<30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. |
| Group 5: Participants With ESRD With or Without Hemodialysis | EXPERIMENTAL | Adult participants with end-stage renal disease (ESRD) (eGFR \<15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment. |
| ALS-008176 (250 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 250 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (500 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 500 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (750 mg) or Placebo | EXPERIMENTAL | Participants will receive ALS-008176, 750 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Lumicitabine | DRUG | Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study. |
| Placebo | DRUG | Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study. |
| JNJ-64041575 | DRUG | All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1. |
| ALS-008176 (250 mg) | DRUG | Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (500 mg) | DRUG | Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions. |
| ALS-008176 (750 mg) | DRUG | Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions. |
Inclusion Criteria: * Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004 * The p...
ALS-008176 is an investigational small molecule developed by Johnson & Johnson for respiratory syncytial virus infections. It is in Phase 1 clinical development and has been studied in healthy adult volunteers. The compound is also referred to as ALS-008176 (250 mg) in some study documentation.
ALS-008176 is being developed for the treatment of respiratory syncytial virus infections, an infectious disease of the respiratory tract. Development remains at the Phase 1 stage, so the drug is investigational and is not yet available as a treatment for RSV.
ALS-008176 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company holds the asset as part of its infectious disease pipeline, and the compound is being studied for respiratory syncytial virus infections.
ALS-008176 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it remains investigational, ALS-008176 has not been approved by the FDA for any indication.
ALS-008176 has been evaluated in one completed Phase 1 trial, NCT02478333, titled a study to investigate the safety, tolerability, and pharmacokinetics of ALS-008176 in healthy Japanese adult participants. That randomized, double-blind, controlled trial enrolled 24 healthy volunteers in Japan.