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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36.
ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36.
Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36.
Unnamed facility
Surrey, United Kingdom
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).
Time frame: Up to Day 36
Maximum Observed Analyte Concentration (Cmax)
The Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 36
Minimum Observed Analyte Concentration (Cmin)
The Cmin is the minimum observed analyte concentration during dosing interval.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to Day 36
Area Under the Analyte Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The (AUC \[0-last\]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to Day 36
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to Follow-up (170 to 175 days after last study drug intake)