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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC1014 | Other Identifier | Janssen Research & Development, LLC |
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The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Severe Renal Impairment): Odalasvir | Experimental | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
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| Cohort 2 (Normal Renal Function): Odalasvir | Experimental | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odalasvir | Drug | Participants will receive odalasvir 25 mg tablet, orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Odalasvir | The Cmax is the maximum observed plasma analyte concentration. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Odalasvir | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Odalasvir | The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours (AUC[0-72]) of Odalasvir | The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Odalasvir |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Baseline, up to follow-up (30 to 35 days after study drug intake) |
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Inclusion Criteria:
Cohorts 1 and 2:
Cohort 1:
Cohort 2:
Exclusion Criteria:
Cohorts 1 and 2:
Cohort 1:
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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 |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States | ||||
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000629482 | odalasvir |
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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. |
| Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Apparent Elimination Half-Life (t1/2) of Odalasvir | Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z). | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Apparent Volume of Distribution (Vd/F) of Odalasvir | The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)]. | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Total Apparent Oral Clearance (CL/F) of Odalasvir | The CL/F is defined as Dose/AUC (0-infinity). | Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose |
| Knoxville |
| Tennessee |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |