Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-63623872 2400 milligram · 1 trial · 1 indication
Electrocardiogram will be collected by Holter monitoring. The measured QT data will be corrected for heart rate using Fridericia (QTcF), Bazett (QTcB), and study-specific power (QTcP) correction methods. The QTcF as primary correction method.
| Arm | Type | Description |
|---|---|---|
| Panel 1: Dose level 1 | EXPERIMENTAL | Participants will receive either treatment A (JNJ-63623872, 2400 milligram (mg) tablet orally once on Day 1) or treatment B \[(placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1\]. |
| Panel 1: Dose level 2 | EXPERIMENTAL | Participants will receive either treatment C (JNJ-63623872, 3000 mg tablet orally once on Day 1) or treatment D \[placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1\]. |
| Panel 2: Treatment EFG | EXPERIMENTAL | Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Panel 2: Treatment FGE | EXPERIMENTAL | Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Panel 2: Treatment GEF | EXPERIMENTAL | Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Panel 2: Treatment GFE | EXPERIMENTAL | Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Panel 2: Treatment FEG | EXPERIMENTAL | Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Panel 2: Treatment EGF | EXPERIMENTAL | Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| JNJ-63623872 2400 milligram (mg) | DRUG | Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1. |
| JNJ-63623872 3000 mg | DRUG | Participants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1. |
| JNJ-63623872 | DRUG | Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2. |
| Moxifloxacin | DRUG | Participants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2. |
| Placebo (Matching with JNJ-63623872 2400 mg) | DRUG | Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1. |
| Placebo (Matching with JNJ-63623872 3000 mg) | DRUG | Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2. |
| Placebo (Matching with JNJ-63623872 Dose) | DRUG | Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2. |
| Placebo (Matching with Moxifloxacin) | DRUG | Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2. |
Inclusion Criteria: * Each participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study * Participant must be willing and able to adhere to the prohibitions and restrictions...
JNJ-63623872 2400 milligram is an investigational small molecule being studied in healthy participants. It is not approved for any disease and is in clinical development to evaluate its effects on cardiac repolarization interval. The drug is being developed by Johnson & Johnson.
Johnson & Johnson (NYSE: JNJ) is developing JNJ-63623872 2400 milligram. The company is conducting clinical trials to assess the drug's safety and effects in healthy volunteers. As of now, the drug is in Phase 1 clinical development.
JNJ-63623872 2400 milligram is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The current Phase 1 trial has been completed, and the drug is not yet available for clinical use.
JNJ-63623872 2400 milligram has one completed clinical trial, NCT02658825, titled "A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants." This Phase 1 study enrolled 66 healthy adults in Belgium and was randomized, double-blind, and controlled.
No, JNJ-63623872 2400 milligram is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The completed study focused on healthy participants to assess cardiac effects, but the drug has not been approved for any medical use.