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| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC1005 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-005639-42 | EudraCT Number |
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The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Treatment A | Experimental | Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1. |
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| Panel 1: Treatment B | Experimental | Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1. |
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| Panel 1: Treatment C | Experimental | Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1. |
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| Panel 2: Treatment D | Experimental | Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1. Each treatment period will be separated by a washout period of 7 days. |
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| Panel 2: Treatment E | Experimental | Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odalasvir (ODV) | Drug | ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Odalasvir (ODV) | The Cmax is the maximum observed analyte concentration. | From Day 1 to Day 14 after intake of ODV |
| Time to Reach Maximum Observed Concentration (Tmax) of ODV | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | From Day 1 to Day 14 after intake of ODV |
| Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV | The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration. | From Day 1 to Day 50-55 after intake of ODV |
| Elimination Rate Constant (Lambda[z]) of ODV | 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. | From Day 1 to Day 50-55 after intake of ODV |
| Elimination Half-Life (t1/2) of ODV | Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). | From Day 1 to Day 50-55 after intake of ODV |
| Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV | 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(last) and C(last)/lambda(z)Íž 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Developement, LLC Clinical Trial | Janssen Research and Developement, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey | United Kingdom |
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| ID | Term |
|---|---|
| C000629482 | odalasvir |
| C000629483 | adafosbuvir |
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| Panel 2: Treatment F | Experimental | Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3. Each treatment period will be separated by a washout period of 7 days. |
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| AL-335 | Drug | AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F. |
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| Placebo | Drug | Matching placebo will be administered. |
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| From Day 1 to Day 50-55 after intake of ODV |
| Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV | Up to 50-55 days after intake of ODV |
| Maximum Observed Concentration (Cmax) of AL-335 | The Cmax is the maximum observed analyte concentration. | From Day 1 to Day 4 after intake of AL-335 |
| Time to Reach Maximum Observed Concentration (Tmax) of AL-335 | The Tmax is defined as actual sampling time to reach maximum observed concentration. | From Day 1 to Day 4 after intake of AL-335 |
| Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335 | The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration. | From Day 1 to Day 4 after intake of AL-335 |
| Elimination Rate Constant (Lambda[z]) of AL-335 | 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. | From Day 1 to Day 4 after intake of AL-335 |
| Elimination Half-Life (t1/2) of AL-335 | Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). | From Day 1 to Day 4 after intake of AL-335 |
| Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335 | 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(last) and C(last)/lambda(z)Íž 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. | From Day 1 to Day 4 after intake of AL-335 |
| Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335 | Up to 30 to 35 days after last intake of AL-335 |