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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922EDI1006 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of daily administration of rabeprazole on the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.
This is an open-label, single-center, fixed-sequence study designed to assess the effects of multiple oral administration of rabeprazole (a PPI) on the pharmacokinetics of a single oral dose of JNJ-42847922 in healthy participants. The study consists of 3 phases: a Screening Phase of approximately 4 weeks (Days -29 to -2); an Open Label Treatment Phase (Days -1 to 7); and an End-of-Study Phase occurring from 7 to 14 days after the last dose of study drug. All participants will receive JNJ-42847922, orally on Day 1 (alone) and Day 6 (along with rabeprazole).Rabeprazole will be administered orally on Day 2 to Day 6. Pharmacokinetics will primarily be for JNJ-42847922, M12 metabolite and M16 metabolite. Participant's safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42847922 Plus Rabeprazole | Experimental | Participants will receive JNJ-42847922, 20 milligram (mg) on Day 1 and Day 6. Participants will receive rabeprazole 20 mg once daily from Day 2 to Day 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 | Drug | JNJ-42847922 will be administered as 20 mg tablet orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of JNJ-42847922 | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of JNJ-42847922 will be reported. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-42847922 | 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(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922 | The Cmax is the maximum observed plasma concentration. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of M12 and M16 | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of M12 and M16. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
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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 |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
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| Rabeprazole | Drug | Rabeprazole will be administered as 20 mg tablet orally. |
|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of M12 and M16 | 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(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
| Maximum Observed Plasma Concentration (Cmax) of M12 and M16 | The Cmax is the maximum observed plasma concentration. | Pre-dose; 10, 20, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 hours after study drug administration on Day 1 and Day 6 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 7 to 14 days after last dose of study drug or early withdrawal) |
| ID | Term |
|---|---|
| C000655226 | seltorexant |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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