Clincosm LogoSign in Get a demo

Drug Interaction Study of ASC42 With Atorvastatin

Sponsor
Gannex Pharma Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05464628
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
1.9
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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)
Actual Study Start Date :
Jul 6, 2022
Anticipated Primary Completion Date :
Aug 22, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atorvastatin and ASC42

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

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by Peak Plasma Concentration (Cmax) in the presence or absence of ASC42 [120 hours]

    2. 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]

    3. 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 Outcome Measures

    1. Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs) [Baseline to Day 30]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICON San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Gannex Pharma Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gannex Pharma Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05464628
    Other Study ID Numbers:
    • ASC42-103
    First Posted:
    Jul 19, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gannex Pharma Co., Ltd.
    ASC42
    Atorvastatin
    Additional relevant MeSH terms:
    Atorvastatin

    Study Results

    No Results Posted as of Jul 29, 2022