This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AL-335 is a prodrug being developed as an orally administered anti-HCV therapeutic.
ACH-3102 is an NS5A inhibitor being developed as an orally administered anti-HCV therapeutic.
Simeprevir is an orally active, small molecule inhibitor of the NS3/4A protease of HCV and indicated for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen.
Biotrial
Rennes, France
Multiple dose PK Profile, Cmax and AUC: effect of ACH-3102 on AL-335 and metabolites
To evaluate the effect of multiple oral doses of ACH-3102, on the multiple oral dose PK of AL-335 and metabolites
Time frame: From screening to Day 28 follow-up visit
Multiple dose PK Profile, Cmax and AUC: effect of Simeprevir on AL-335 and metabolites
To evaluate the effect of multiple oral doses of Simeprevir, on the multiple oral dose PK of AL-335 and metabolites
Time frame: From screening to Day 24 visit
Multiple dose PK Profile, Cmax and AUC: effect of ACH-3102 and Simeprevir on AL-335 and metabolites
To evaluate the effect of multiple oral doses of ACH-3102 and Simeprevir, on the multiple oral dose PK of AL-335 and metabolites
Time frame: From screening to Day 28 follow-up visit
Safety Data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results
Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results (including chemistry, hematology, and urine).
Time frame: From screening to Day 28 follow-up visit
Steady-state PK Profile from Clast, t1/2, Tmax, Tlast, CL/F, Vz/F, λz: effect of AL-335 and ACH-3102 on Simeprevir
To determine the potential effect of AL-335 and/or ACH-3102 on the steady-state PK of Simeprevir.
Time frame: From screening to Day 28 follow-up visit
Steady-state PK Profile from Clast, t1/2, Tmax, Tlast, CL/F, Vz/F, λz: effect of AL-335 and Simeprevir on ACH-3102
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To determine the potential effect of AL-335 and/or Simeprevir on the steady-state PK of ACH-3102.
Time frame: From screening to Day 28 follow-up visit