Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-38877618 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| JNJ-38877618 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNJ-38877618: Part 1a | DRUG | Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. |
| JNJ-38877618: Part 1b | DRUG | Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. |
| JNJ-38877618: Part 1c (optional) | DRUG | Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. |
| JNJ-38877618: Part 2 | DRUG | Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg. |
| JNJ-38877618: Part 3 | DRUG | Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally. |
| JNJ-38877618: Part 4 (optional) | DRUG | Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort. |
| Placebo: Parts 1a, 2, 3, and 4 (optional) | DRUG | Administered orally matched to study drug |
Inclusion Criteria: * Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1 * Must have good exercise tolerance * Agrees to protocol-defined use of effec...
JNJ-38877618 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy male volunteers to assess its safety, tolerability, and pharmacokinetics. The specific disease or condition it is intended to treat has not been disclosed.
JNJ-38877618 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 trial of the drug in the United Kingdom.
JNJ-38877618 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA or any regulatory agency for any indication.
JNJ-38877618 has been studied in one completed Phase 1 trial, NCT01964872. The trial enrolled 84 healthy male participants in the United Kingdom and evaluated the safety, tolerability, and pharmacokinetics of the drug. It was randomized, double-blind, and placebo-controlled.
Yes, JNJ-38877618: Part 1a, Part 1b, Part 1c, Part 2, Part 3, and Part 4 are alternative names or sub-study designations for JNJ-38877618. These labels refer to different parts of the clinical program for the same investigational drug.