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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004189-16 | EudraCT Number | ||
| 64417184RSV1007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Treatment Sequence ABDC | Experimental | Participants will receive Treatment A (a single dose of JNJ-64417184 [oral solution with preservatives] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 [oral solution with preservatives] in fed [high-fat meal] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 [oral solution without preservatives] in fed [high-fat meal] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 [oral solution without preservatives] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Panel 1: Treatment Sequence BCAD | Experimental | Participants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Panel 1: Treatment Sequence CDBA | Experimental | Participants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Panel 1: Treatment Sequence DACB |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64417184 | Drug | Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 | Cmax is the maximum observed plasma analyte concentration. | Up to Day 6 |
| Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184 | AUC (0-last) is area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Up to Day 6 |
| Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184 | AUC (0-infinity) is the area under the plasma analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant. | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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 28 days |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | 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 Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence EFG | Experimental | Participants will receive Treatment E (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fed [high-fat meal] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fed [high-fat meal] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence FGE | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence GEF | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence GFE | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence EGF | Experimental | Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Optional Panel 2: Treatment Sequence FEG | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes. |
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| Acceptability of the JNJ-64417184 Formulation as Assessed by Participant |
The acceptability of the JNJ-64417184 formulations will be assessed by the participants using a questionnaire designed to rate the taste and smell as well as the overall acceptability of the formulations. The questionnaire will consist of a visual analogue scale to rate 5 items (sweetness, bitterness, aroma type, aroma strength, and smell) as well as overall acceptability. |
| Up to 28 days |