Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04844411 | A Study of JNJ-67835989 in Healthy Participants | PHASE1 | COMPLETED | 109 | — | — | Apr 27, 2021 | May 18, 2022 | Apr 27, 2025 | 1 | Belgium |
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 ...