Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT04843449 |
Recruitment Status :
Completed
First Posted : April 13, 2021
Last Update Posted : August 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: ASC40 Drug: Itraconazole Drug: rifampicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Open Label, Drug-drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects |
Actual Study Start Date : | April 4, 2021 |
Actual Primary Completion Date : | May 6, 2021 |
Actual Study Completion Date : | May 14, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Inhibitor group
|
Drug: ASC40
Oral tablets Drug: Itraconazole Oral capsules |
Experimental: Inducer group
|
Drug: ASC40
Oral tablets Drug: rifampicin Oral capsules |
- AUC of ASC40 [ Time Frame: Up to 24 days ]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.
- Cmax of ASC40 [ Time Frame: Up to 24 days ]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.
- t1/2 of ASC40 [ Time Frame: Up to 24 days ]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.
- CL/F of ASC40 [ Time Frame: Up to 24 days ]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.
- Vd/F of ASC40 [ Time Frame: Up to 24 days ]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.
- 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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
-19kg/m2 ≤ BMI <40kg/m2.
Key Exclusion Criteria:
- History of, or current digestive system, nervous system disease, etc..
- Taking drugs or foods that inhibit or induce the liver's metabolism.

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): NCT04843449
China, Hunan | |
Hunan provincial people's hospital | |
Changsha, Hunan, China |
Responsible Party: | Ascletis Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04843449 |
Other Study ID Numbers: |
ASC40-102 |
First Posted: | April 13, 2021 Key Record Dates |
Last Update Posted: | August 23, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Healthy Volunteers DDI (Drug-Drug Interaction) Itraconazole Rifampicin ASC40 |
Itraconazole Rifampin Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Cytochrome P-450 CYP3A Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |