A Phase 1 interventional study of ASC40 and Itraconazole in Healthy, sponsored by Ascletis Pharmaceuticals Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Ascletis Pharmaceuticals Co., Ltd. (part of Ascletis Pharma Inc.) · Phase 1, Interventional, and Treatment
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.
Ascletis Pharmaceuticals Co., Ltd. is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
-19kg/m2 ≤ BMI \<40kg/m2.
Key Exclusion Criteria:
1. ASC40 50mg, once daily on the 1st and 11th days before meal; 2. Itraconazole 200mg, once daily from the 6th day to the 15th day.
Drug: ASC40 · Drug: Itraconazole
1. ASC40 50mg, once daily on the 1st and 19th days before meal; 2. Rifampicin 600mg, once daily from the 6th day to the 19th day.
Drug: ASC40 · Drug: rifampicin
Oral tablets
Oral capsules
Oral capsules
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in May 2021, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: TVB-2640 · Itraconazole
Ascletis Pharmaceuticals Co., Ltd. →