Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lumicitabine · 2 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.
Cmax is the maximum observed plasma concentration.
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non BQL\]) concentration, calculated by linear trapezoidal summation.
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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Tmax is the actual sampling time to reach maximum observed plasma concentration.
C12h is observed plasma concentration at 12 hours post dose.
C24h is observed plasma concentration at 24 hours post dose.
Lambda\[z\] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data.
T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z).
| 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. |
| Treatment Sequence 1 (AB) | EXPERIMENTAL | Participants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4\*250 mg tablets) on Day 1 of period 1 followed by Treatment B as a single oral dose of 1000 mg lumicitabine (4\*250 mg tablets) together with piperacillin/tazobactam administered as three 30-minute Intravenous (IV) infusions of 4.5 gram (g) piperacillin/tazobactam (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1 of period 2. A washout period of at least 21 days will be maintained between each treatment period. |
| Treatment Sequence 2 (BA) | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. A washout period of at least 21 days will be maintained between each treatment period. |
| 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. |
| Piperacillin/Tazobactam | DRUG | Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1. |
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...
Lumicitabine is an investigational small molecule being studied for Respiratory Syncytial Virus (RSV) infections. It has been evaluated in clinical trials involving healthy adults and in infants and children with a history of RSV infection. The drug is not approved and remains in clinical development.
Lumicitabine is being developed by Johnson & Johnson (NYSE: JNJ). The company has conducted clinical trials of the drug for Respiratory Syncytial Virus infections, including studies in healthy volunteers and in pediatric patients with a history of RSV infection.
Lumicitabine is in clinical development, with trials listed as Phase 1 and Phase 2. One completed Phase 1 study assessed the drug in healthy adults, and a completed Phase 2 study evaluated its long-term impact in infants and children. It is not FDA approved.
Lumicitabine has been studied in two completed trials. NCT03441529 was a Phase 1 crossover study in healthy adults in Belgium. NCT03332459 was a Phase 2 long-term follow-up study in infants and children with a history of RSV infection in Japan.
Yes, Lumicitabine is also known as JNJ-64041575. The Phase 1 study NCT03441529 refers to the drug as Lumicitabine (JNJ-64041575), confirming that these names refer to the same investigational compound.