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| ID | Type | Description | Link |
|---|---|---|---|
| TMC435HPC1007 |
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The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.
This is an open-label (all people know the identity of the intervention), single-center, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical trial) and randomized (the study drug is assigned by chance) study to assess the effect of food on the pharmacokinetics of TMC435 after a single dose in Japanese healthy adult male participants. The study duration will be of 44 days per participant, which is divided into 3 parts: Screening (from Day -28 to Day -2); Treatment (consists of 2 treatment periods of 5 days each [that is, Day -1 to 4, in-patient period], wherein all participants will receive TMC435 in the respective period, and the period will be separated by washout period of 9 days); and Follow-up (on Day 7 of Period 2). Participants will keep upright position from the time of study drug administration until 4 hours after study drug administration. Participants will not be allowed to ingest meal until 4 hours post-dose. Participants will have standardized lunch and dinner at 4 hours and 10 hours post-dose, respectively. Drinking water will not be allowed from 1 hour before the administration up to 1 hour after administration except for the water served with the study drug and meal. Pharmacokinetics will be assessed in blood samples which will be collected up to 72 hours after administration of study drug. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC435 in fasted then fed condition | Experimental | Participants under fasting condition will be administered with TMC435, 100 milligram (mg) as oral capsule on Day 1 of first treatment period and then will be administered with TMC435, 100 mg oral capsule on Day 1 under fed condition of second treatment period (after washout period of 9 days, between the two treatment periods). |
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| TMC435 in fed then fasted condition | Experimental | Participants under fed condition will be administered with TMC435, 100 milligram (mg) as oral capsule on Day 1 of first treatment period and then will be administered with TMC435, 100 mg oral capsule on Day 1 under fasting condition of second treatment period (after washout period of 9 days, between the two treatment periods). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC435 | Drug | TMC435, 100 milligram oral capsule will be administered on Day 1 of each treatment period, separated by washout period of 9 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (C[max]) | The C(max) is the maximum plasma concentration. | -3 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 1 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[infinity]) | The AUC (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; and C (last) is the last observed quantifiable concentration; and lambda (z) is elimination rate constant. | -3 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 1 |
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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 |
|---|---|---|---|---|---|---|
| Toshima City | Japan |
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| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |