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| ID | Type | Description | Link |
|---|---|---|---|
| 54135419EDI1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-004129-25 | EudraCT Number |
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The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-54135419 | Experimental | Participants will receive a single oral dose of JNJ-54135419-AAA oral solution for sublingual administration in 1 of 3 serial dose escalating cohorts in fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54135419 | Drug | Single dose of JNJ-54135419 oral solution will be administered sublingually. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of (S)-ketamine | Observed plasma concentrations of (S)-ketamine will be reported. | Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
| Plasma Concentrations of Nor-(S)-ketamine | Observed plasma concentrations of nor-(S)-ketamine will be reported. | Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Vital Sign Abnormalities | Number of participants with vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP]) abnormalities will be reported. | Up to 4 Weeks |
| Number of Participants with Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services | Antwerp | 2060 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. |
| Up to 4 Weeks |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |