How laroprovstat and AZD4954 change each other's drug levels in healthy adults

An Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults.

The trial will test whether taking laroprovstat and AZD4954 together changes how much of each drug is in the body in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Glendale, California)
• Trial ID: NCT07513571 on ClinicalTrials.gov

What this trial studies

This open-label, fixed-sequence Phase 1 study gives single doses of AZD4954, laroprovstat, and then both together to healthy adult volunteers across two cohorts and two treatment periods. Cohort 1 receives AZD4954 alone followed by the combination, and Cohort 2 receives laroprovstat alone followed by the combination. Serial blood sampling will measure pharmacokinetic parameters to compare drug levels when each drug is given alone versus together. The study includes screening, two treatment periods, and follow-up visits to monitor safety and PK results.

Who should consider this trial

Good fit: Healthy adult men and women who meet screening criteria, are not pregnant or lactating, agree to contraception if applicable, have a BMI of 18–35 kg/m2, and weigh at least 50 kg.

Not a fit: People with active medical conditions, a history of gastrointestinal, hepatic, or renal disease, or those taking medications that affect drug metabolism would not be eligible and would not benefit from participating.

Why it matters

Potential benefit: If successful, the results could show whether the drugs can be safely given together and whether dose changes are needed.

How similar studies have performed: Drug–drug interaction pharmacokinetic studies are routine in development and have previously guided safe co‑administration and dosing of other medications.

Eligibility criteria

Inclusion Criteria:

* All females must have a negative pregnancy test at the Screening Visit.
* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
* Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Participants with known bleeding or coagulation disorders.
* Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
* Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.
* Participants who are current smokers or have used any tobacco or nicotine-containing products (including e-cigarettes) within 3 months prior to screening; known or suspected history of alcohol or drug abuse; positive screen for drugs of abuse, alcohol, or cotinine at screening or on each admission to the Clinical Unit.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs of a similar chemical structure or class to AZD4954 or laroprovstat.
* Participants who have previously received AZD4954.
* Treatment with any lipid-lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.

Where this trial is running

Glendale, California

• Research Site — Glendale, California, United States (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Pharmacokinetics; Drug-drug interaction; Dyslipidemias; Hypercholesterolemia; Lipoprotein