Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 64294178HPC1006 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-000950-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy Japanese participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-335+Simeprevir (SMV)+Odalasvir (ODV) | Experimental | Participants will receive AL-335 800 milligram (mg) once daily from day 1-3; SMV 75 mg once daily from Day 4-13; loading dose of ODV 150 mg on Day 14, followed by ODV 50 mg once daily from Day 15 to 23; ODV 50 mg once daily + AL-335 800 mg once daily from day 24-26; ODV 50 mg once daily + SMV 75 mg once daily from Day 27-33 and ODV 50 mg once daily + SMV 75 mg once daily + AL-335 800 mg once daily from Day 34 to 36. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-335 | Drug | AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Analyte Concentration at Steady State (Cavg,ss) | The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau). | Up to Day 36 |
| Maximum Observed Analyte Concentration (Cmax) | The Cmax is the maximum observed analyte concentration. | Up to Day 36 |
| Minimum Observed Analyte Concentration (Cmin) | The Cmin is the minimum observed analyte concentration during dosing interval. | Up to Day 36 |
| Trough Plasma Concentration (Ctrough) | The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen. | Up to Day 36 |
| Time to Reach Maximum Observed Analyte Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Up to Day 36 |
| Area Under the Analyte Concentration-Time Curve From Time 0 to 24 Hours (AUC24) | The AUC24 is the area under the analyte concentration-time curve from time 0 to 24 hours. | Up to Day 36 |
| Fluctuation Index (FI) | Fluctuation Index is defined as percentage of fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability | Up to Follow-up (170 to 175 days after last study drug intake) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Odalasvir (ODV) | Drug | ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36. |
|
| Simeprevir (SMV) | Drug | Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36. |
|
| Up to Day 36 |
| Area Under the Analyte Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) | The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration. | Up to Day 36 |
| Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | 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); 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. | Up to Day 36 |
| Elimination Rate Constant (Lambda[z]) | 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. | Up to Day 36 |
| Elimination Half-Life (t1/2) | 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). | Up to Day 36 |
| ID | Term |
|---|---|
| C000629483 | adafosbuvir |
| C000629482 | odalasvir |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided