The primary objective of this study is to evaluate the effects of itraconazole (a strong inhibitor of cytochrome P450 3A (CYP3A)) and rifampicin (a strong inducer of CYP3A) on the pharmacokinetics of ASC40 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Hunan provincial people's hospital
Changsha, Hunan, China
AUC of ASC40
Evaluate the Area under the Plasma Concentration Versus Time Curve after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Time frame: Up to 24 days
Cmax of ASC40
Evaluate the Peak Plasma Concentration after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Time frame: Up to 24 days
t1/2 of ASC40
Evaluate the Terminal-Phase Half-Life after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Time frame: Up to 24 days
CL/F of ASC40
Evaluate the Apparent Systemic Clearance after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Time frame: Up to 24 days
Vd/F of ASC40
Evaluate the Apparent Volume of Distribution after single oral dose of ASC40 administered to healthy volunteers in the presence or absence of CYP3A inhibitor or inducer.
Time frame: Up to 24 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 24 days.
Time frame: Up to 24 days
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