Drug Interaction Study of ASC42 With Atorvastatin

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464628
• Other study ID #: ASC42-103
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2024
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Atorvastatin
Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin
• ASC42
Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin

Locations

Country	Name	City	State
United States	ICON	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by Peak Plasma Concentration (Cmax) in the presence or absence of ASC42		120 hours
Primary	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
Primary	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	Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs)		Baseline to Day 30