Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 64041575RSV1002 | Other Identifier | Janssen-Cilag International NV | |
| 2016-003923-49 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of multiple-dose administration of probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of JNJ-64041575 in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence AB | Experimental | Participants will receive Treatment A (1000 milligram (mg) oral dose of JNJ-64041575 on Day 1) in Period 1, followed by Treatment B (1000 mg oral dose of JNJ-64041575 on Day 22 along with probenecid 500 mg on Day 21 to Day 28) in Period 2. A washout Period of 21 days will be maintained between each Period. |
|
| Treatment sequence BA | Experimental | Participants will receive Treatment B (1000 mg oral dose of JNJ-64041575 on Day 1 along with probenecid 500 mg on Day -1 to Day 7) in Period 1, followed by Treatment A (1000 mg oral dose of JNJ-64041575 on Day 22) in Period 2. A washout Period of 21 days will be maintained between each Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64041575 | Drug | Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ-64041575) | Cmax is the maximum observed plasma concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-63549109 (Metabolite of JNJ-64041575) | Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63549109 (Metabolite of JNJ-64041575) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z)Íž wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-64167896 (Metabolite of JNJ-64041575) | Cmax is the maximum observed plasma concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-64167896 (Metabolite of JNJ-64041575) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CharitĂŠ Research Organisation GmbH | Berlin | 10117 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Probenecid | Drug | One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days). |
|
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation. |
| Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64167896 (Metabolite of JNJ-64041575) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z)Íž wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From Signing of Informed Consent Form (ICF) to End of Study (Approximately up to 88 days) |
| ID | Term |
|---|---|
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided