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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive odalasvir 100 milligram (mg) or odalasvir matching placebo once on Day 1. |
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| Treatment B | Experimental | Participants will receive odalasvir 500 mg or odalasvir matching placebo once on Day 1. |
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| Treatment C | Experimental | Participants will receive odalasvir (dose to be determined based on pharmacokinetic data from treatment A and B but no more than 1000 mg) or odalasvir matching placebo once on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odalasvir 100 mg | Drug | Participants will receive odalasvir 2*50 mg tablet, orally once on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis | A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time. | Baseline up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Odalasvir | Cmax is the maximum observed analyte concentration. | 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir |
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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 |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Placebo | Drug | Participants will receive odalasvir matching placebo, tablet, orally once on Day 1. |
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| Odalasvir 500 mg | Drug | Participants will receive odalasvir 10*50 mg tablet, orally once on Day 1. |
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| Odalasvir (Up to maximum 1000 mg) | Drug | Participants will receive odalasvir to be decided up to maximum of 20*50 mg tablet, orally once on Day 1. |
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AUC(0-last) is the area under the plasma concentration-time curve from time zero to the last quantifiable time. |
| 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Odalasvir | 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(last)/lambda(z); wherein AUC(0-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. | 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1 |
| PR Interval Changes and the Relationship Between the Plasma Concentrations of Odalasvir and PR Interval Changes Using ER Analysis | A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in the PR interval over time. | Baseline up to Day 4 |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | up to Day 65 |
| ID | Term |
|---|---|
| C000629482 | odalasvir |
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