Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-67835989 · 1 trial · 1 indication
Number of participants with abnormalities in vital signs (heart rate \[HR\], systolic blood pressure \[SBP\], diastolic blood pressure \[DPB\]), respiratory rate, pulse oximetry and temperature will be reported.
Number of participants with clinically significant clinical laboratory abnormalities (chemistry, hematology, urinalysis) will be reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of participants with abnormalities in ECG will be reported.
Plasma samples will be analyzed to determine concentrations of JNJ-67835989 and possible metabolites using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC MS/MS) method.
Urine samples will be analyzed to determine JNJ-67835989 and possible metabolites concentrations using a qualified research LC-MS/MS method.
CADSS is an instrument for the measurement of present-state dissociative symptoms and will be administered to assess treatment-emergent dissociative symptoms. CADSS consists of 23 subjective items, divided into 3 components: depersonalization (items 3 to 7, 20, and 23), derealization (items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (items 14, 15, and 22). The participants responses are coded on a 5-point scale (from 0 equals to \[=\] not at all to 4=extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
The MOAA/S will be used to measure treatment-emergent sedation, with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum. The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-67835989 (Oral Suspension) | EXPERIMENTAL | Participants will receive a single oral suspension dose of JNJ-67835989 on Day 1 in Part 1 and Part 2. |
| Arm B: Placebo | PLACEBO_COMPARATOR | Participants will receive a single oral solution placebo on Day 1 in Part 1 only (except food effect cohorts). |
| Arm C: JNJ-67835989 (Oral Solid Dose) | EXPERIMENTAL | Participants will receive a single oral solid dose (tablet) of JNJ-67835989 on Day 1 in Part 3. |
| Name | Type | Description |
|---|---|---|
| JNJ-67835989 | DRUG | JNJ-67835989 will be administered orally. |
| Placebo | DRUG | Matching placebo will be administered orally. |
Inclusion Criteria: * Healthy on the basis of physical and neurological examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The ...
JNJ-67835989 is an investigational small molecule drug developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy participants. No therapeutic indication for JNJ-67835989 has been disclosed, and the compound remains in early clinical development.
JNJ-67835989 is made and developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound in healthy participants.
JNJ-67835989 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any use.
JNJ-67835989 has been evaluated in one clinical trial, NCT04844411, titled A Study of JNJ-67835989 in Healthy Participants. The Phase 1 trial enrolled 109 participants in Belgium, was randomized, double-blind, and placebo-controlled, and is now completed.
The Phase 1 trial NCT04844411 enrolled 109 healthy male volunteers aged 18 years and older in Belgium. It was a randomized, double-blind, placebo-controlled study, and it has been completed.