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| ID | Type | Description | Link |
|---|---|---|---|
| 61393215EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of this study is to assess the effect of ritonavir, on the single-dose pharmacokinetics (PK) of JNJ-61393215 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-61393215 2 mg + Ritonavir 100 mg | Experimental | Participants will receive suspension of JNJ-61393215 2 mg (Day 1 and 5) orally and tablet of Ritonavir 100 mg twice a Day (Day 4-14) orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61393215 | Drug | Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-61393215 | Cmax is the maximum observed plasma concentration. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| Last Quantifiable Plasma Concentration (Clast) of JNJ-61393215 | Clast is the last quantifiable Plasma concentration. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393215 | Tmax is the time to reach maximum plasma concentration. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393215 | Tlast is the time to last observed quantifiable plasma concentration. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| Area Under Plasma-Concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of JNJ-61393215 | AUClast is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Event as a Measure of Safety and Tolerability | An adverse event 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. | Approximately 8 weeks |
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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 International | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Ritonavir | Drug | Participants will receive 100 mg of ritonavir tablet orally. |
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| Area Under Plasma-Concentration Curve from Time 0 to Infinite Time (AUCinfinity) of JNJ-61393215 | AUCinfinity 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. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| First-Order Rate Constant Associated with the Terminal Portion of the Curve [Lambda(z)] of JNJ-61393215 | Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. | Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h) |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |