Drug Interaction Study of ASC42 With Atorvastatin

NCT05464628 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC42-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

ASC42; Atorvastatin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs)

  Baseline to Day 30

Study Arms (1)

Atorvastatin and ASC42

EXPERIMENTAL

Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin.

Drug: Atorvastatin; Drug: ASC42

Interventions

Atorvastatin DRUG

Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin

Also known as: Lipitor

Atorvastatin and ASC42

ASC42 DRUG

Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin

Atorvastatin and ASC42

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

Study Sites (1)

ICON

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: August 8, 2022
• Primary Completion: August 23, 2022
• Study Completion: August 30, 2022
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

US (1)