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 a 2400 mg dose of an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy participants. The therapeutic indication for this dose has not been disclosed.
JNJ-63623872 2400 milligram is made by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson is the developer of the compound and sponsored the clinical trial evaluating this dose.
JNJ-63623872 2400 milligram is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial for this dose has been completed.
JNJ-63623872 2400 milligram has been evaluated in one clinical trial: NCT02658825, titled "A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants." The trial was a completed Phase 1 study conducted in Belgium with 66 healthy participants.