Skip to main content
OpenTrials
Completed

NCT Number: NCT05464628

Drug Interaction Study of ASC42 With Atorvastatin

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

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

Other names: Lipitor

ASC42

Drug

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

Primary outcomes

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

    Time frame: 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))

    Time frame: 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

    Time frame: 120 hours

Secondary outcomes

  1. Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs)

    Time frame: Baseline to Day 30

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.