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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004428-39 | EudraCT Number | ||
| 54135419EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: OTF 1, 4, 2, 3 | Experimental | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 1 in period 1; followed by OTF 4 in period 2; followed by OTF 2 in period 3; followed by OTF 3 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
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| Treatment Sequence 2: OTF 2, 1, 3, 4 | Experimental | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 2 in period 1; followed by OTF 1 in period 2; followed by OTF 3 in period 3; followed by OTF 4 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
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| Treatment Sequence 3: OTF 3, 2, 4, 1 | Experimental | Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 3 in period 1; followed by OTF 2 in period 2; followed by OTF 4 in period 3; followed by OTF 1 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period. |
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| Treatment Sequence 4: OTF 4, 3, 1, 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTF 1 | Drug | Participants will receive (S)-ketamine administered sublingually through OTF 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Maximum plasma concentration will be reported. | Up to 24 hours |
| Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)] | Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported. | Up to 24 hours |
| Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)] | Area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda, in which C(last) is the last observed quantifiable concentrations will be reported. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinically Significant Abnormalities in Vital sign (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) | Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) will be reported. | Day 1 |
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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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Participants will receive a single dose of (S)-ketamine administered sublingually through OTF 4 in period 1; followed by OTF 3 in period 2; followed by OTF 1 in period 3; followed by OTF 2 in period 4, on Day 1 of each treatment period under fasted conditions. A washout period of at least 72 hours will be maintained between each treatment period.
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| OTF 2 | Drug | Participants will receive (S)-ketamine administered sublingually through OTF 2. |
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| OTF 3 | Drug | Participants will receive (S)-ketamine administered sublingually through OTF 3. |
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| OTF 4 | Drug | Participants will receive (S)-ketamine administered sublingually through OTF 4. |
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| Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate) |
Number of participants with clinically significant abnormalities in vital sign (heart rate) will be reported. |
| Day 1 |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs) | Number of participants with clinically significant abnormalities in ECG will be reported. | Day 1 and 2 |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported. | Day 1 and 2 |
| Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability | 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. | Up to Day 7 |