Drug Interaction Study of ASC42 With Atorvastatin

NCT ID: NCT05464628

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2022-08-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Atorvastatin and ASC42

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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

ASC42

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

ASC42

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

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gannex Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICON

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ASC42-103

Identifier Type: -

Identifier Source: org_study_id

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