Clinical trial NCT05464628: Drug Interaction Study of ASC42 With Atorvastatin
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ASC42
Atorvastatin
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by Peak Plasma Concentration (Cmax) in the presence or absence of ASC42
timeFrame: 120 hours
measure: 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))
timeFrame: 120 hours
measure: Evaluate the pharmacokinetics (PK) of atorvastatin and its two metabolites by time to peak plasma concentration (Tmax) in the presence or absence of ASC42
timeFrame: 120 hours
Secondary outcomes:
measure: Safety and tolerability of Atorvastatin in the presence of ASC42 evaluated by incidence of treatment emergent adverse events (TEAEs)
timeFrame: Baseline to Day 30
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON
state: Texas
Study officials:
References: