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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.
This is an open-label (both [participants and investigator] know what treatment participants will receive) and randomized (study medication is assigned by chance) study. The study consists of 3 phases: a screening phase (within 21 days prior to administration of study medication), a treatment phase (from day -1 [1 days before the administration of study medication] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up to 16 days after the last dose of study medication or after dropout [other than withdrawal of consent]). Approximately 32 healthy participants will be equally divided into 2 groups (Group 1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant will be approximately 47 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive 100 mg TMC435 once daily for 7 days. |
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| Group 2 | Experimental | Participants will receive 150 mg TMC435 once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC435 100 mg | Drug | Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food. |
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| Measure | Description | Time Frame |
|---|---|---|
| Predose plasma concentration of TMC435 | Predose on Days 1, 5, 6, and 7 | |
| Minimum plasma concentration of TMC435 | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Maximum plasma concentration of TMC435 | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Time to reach the maximum plasma concentration of TMC435 | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Area under the plasma concentration-time curve of TMC435 from time of administration up to 24 hours after dosing | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Area under the plasma concentration-time curve of TMC435 from time of administration up to the last time point with a measurable concentration after dosing | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Average steady-state plasma concentration of TMC435 | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) | |
| Fluctuation index of TMC435 | Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration. | Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 47 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 |
|---|---|---|---|---|---|---|
| Beijing | China |
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| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| TMC435 150 mg | Drug | Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food. |
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| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |