Drug Interaction Study of ASC42 With Atorvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Atorvastatin; Drug: ASC42

• Registration Number: NCT05464628
• Lead Sponsor: Gannex Pharma Co., Ltd.

Brief Summary

The purpose of this study is to determine whether ASC42 alters the pharmacokinetics of atorvastatin in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Study Start: 2022-08-08
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy male and female subjects between 18 to 65 years of age
• Willing and able to give informed consent prior to any procedures
• Weight at least 50 kg and have a body mass index (BMI) within the range of 19-32 kg/m^2, inclusive at screening.
• A female participant is eligible to participate in this study if: She is of non-childbearing potential. She is of childbearing potential and is non-pregnant or non-lactating and willing to use adequate contraception from screening until 30 days after the End of Study visit.
• Physical examination and vital signs are within normal range or slightly abnormal but nonclinical significance.

Exclusion Criteria

• Females with childbearing potential if no dual safe anticontraception method is provided.
• Male subjects whose female partner is currently pregnant or wanting to become pregnant or sexually active subjects if methods of contraception are not used during the trial and for 30 days following their final study drug.
• ALT or AST >ULN or Direct bilirubin >ULN
• Total Bilirubin >ULN with any single parameters of ALT, AST, ALP or GGT > ULN
• Elevated creatine kinase (CK) at screening (one repeat test allowed)
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or may jeopardize the safety of the participants.
• Platelet count <150,000/mcL or INR> 1.2
• History of , or current electrocardiogram abnormalities, arrythmias or heart valve diseases.
• History of drug or food allergies that caused severe hypersensitivity.
• History of intolerance to or adverse event reaction to a statin, or history of myopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin and ASC42	ASC42	Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin.
Atorvastatin and ASC42	Atorvastatin	Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin.

Primary Outcome Measures

Name	Time	Method
Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by Peak Plasma Concentration (Cmax) in the presence or absence of ASC42	120 hours
Evaluate the pharmacokinetics (PK) of Atorvastatin and its two metabolites in the presence of ASC42 by Area under the curve from the time of dosing extrapolated to infinity (AUC(0-inf))	120 hours
Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by time to peak plasma concentration (Tmax) in the presence or absence of ASC42	120 hours

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs)	Baseline to Day 30

Trial Locations

Locations (1)

ICON; 🇺🇸 San Antonio, Texas, United States