Study Results
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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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2022-08-08
2022-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Atorvastatin and ASC42
Atorvastatin followed by ASC42 daily followed by separate co-administration of atorvastatin.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Gannex Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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ICON
San Antonio, Texas, United States
Countries
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Other Identifiers
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ASC42-103
Identifier Type: -
Identifier Source: org_study_id
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