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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002695-13 | EudraCT Number | ||
| 64417184RSV1003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: Treatment ABC | Experimental | Participants will receive Treatment A (JNJ-53718678 once daily for 7 days) in Treatment Period 1, followed by Treatment B (JNJ-64417184 once daily for 7 days) in Treatment Period 2, followed by Treatment C (JNJ-53718678 once daily + JNJ-64417184 once daily for 7 days) in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods. |
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| Treatment Sequence 2: Treatment BCA | 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. There will be a washout period of at least 7 days between the treatment periods. |
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| Treatment Sequence 3: Treatment CAB | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods. |
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| Treatment Sequence 4: Treatment ACB | Experimental | Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-53718678 | Drug | JNJ-53718678 suspension will be administered orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678 | Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval. | Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose |
| Ctrough of JNJ-64417184 | Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval. | Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose |
| Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-53718678 | Cmax is defined as maximum observed plasma analyte concentration. | Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose |
| Cmax of JNJ-64417184 | Cmax is defined as maximum observed plasma analyte concentration. | Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose |
| Area Under the Plasma Concentration-time Curve from Time of Administration up to 24 Hours Postdose (AUC[24h]) of JNJ-53718678 | AUC24h is defined as AUC from time 0 to 24 hours postdose. | Up to 24 hours postdose |
| AUC24h of JNJ-64417184 | AUC24h is defined as AUC from time 0 to 24 hours postdose. | Up to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to 42 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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
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 |
|---|---|
| C000624632 | JNJ-53718678 |
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| Treatment Sequence 5: Treatment BAC | Experimental | Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods. |
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| Treatment Sequence 6: Treatment CBA | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3. There will be a washout period of at least 7 days between the treatment periods. |
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| JNJ-64417184 | Drug | JNJ-64417184 tablet will be administered orally as per assigned treatment sequence. |
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