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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
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.
Matching placebo will be administered.
Unnamed facility
Surrey, United Kingdom
Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
The Cmax is the maximum observed analyte concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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); 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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Time frame: 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
Time frame: Up to 50-55 days after intake of ODV
Maximum Observed Concentration (Cmax) of AL-335
The Cmax is the maximum observed analyte concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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); 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: 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
Time frame: Up to 30 to 35 days after last intake of AL-335