Drug Interaction Study of ASC42 With Atorvastatin

Gannex Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASC42; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05464628

ASC42-103

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Atorvastatin and ASC42

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

Drug: ASC42