DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
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|ClinicalTrials.gov Identifier: NCT04845646|
Recruitment Status : Completed
First Posted : April 15, 2021
Last Update Posted : July 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy NAFLD||Drug: ASC41 Drug: Itraconazole Drug: Phenytoin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Open Label, Drug-Drug Interaction, Study to Evaluate the Effect of Itraconazole and Phenytoin on the Pharmacokinetics of ASC41 in Healthy Volunteers and A Study to Evaluate the PK, Safety and Tolerability in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD).|
|Actual Study Start Date :||March 16, 2021|
|Actual Primary Completion Date :||June 10, 2021|
|Actual Study Completion Date :||June 10, 2021|
Experimental: ASC41 + Itraconazole group
Experimental: ASC41 + Phenytoin group
Experimental: ASC41 group
(1) ASC41 5 mg po. One 5 mg ASC41 tablet on day 1.
- AUC of ASC41 [ Time Frame: Up to 24 days ]Evaluate the Area under the plasma concentration versus time curve.
- Cmax of ASC41 [ Time Frame: Up to 24 days ]Evaluate the Peak Plasma Concentration.
- t1/2 of ASC41 [ Time Frame: Up to 24 days ]Evaluate the Terminal-Phase Half-Life.
- CL/F of ASC41 [ Time Frame: Up to 24 days ]Evaluate the Apparent Systemic Clearance.
- Vd/F of ASC41 [ Time Frame: Up to 24 days ]Evaluate the Apparent Volume of Distribution.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 24 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845646
|United States, Texas|
|ICON early Phase Services LLC|
|San Antonio, Texas, United States, 78209|