Drug Interaction Study of ASC42 With Atorvastatin

A Phase 1, Open-Label, Drug-Drug Interaction, Study to Evaluate the Effect of ASC42 on the Pharmacokinetics of Atorvastatin Tablets in Healthy Volunteers (HVs)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Atorvastatin; Drug: ASC42

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin and ASC42; Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin.	Drug: Atorvastatin; Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin; Other Names: Lipitor; Drug: ASC42; Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Gannex Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Atorvastatin; ASC42
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: ASC42-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No