A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa 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 purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on the PK of laroprovstat in healthy male and female participants.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AZD4954; Drug: Laroprovstat

Detailed Description

This is an open-label, fixed-sequence, 2 period and 2 cohort study in healthy participants.

Each participant in each cohort will receive treatments in a fixed order during the 2 treatment periods as follows:

• Cohort 1: Treatment A followed by Treatment C.
• Cohort 2: Treatment B followed by Treatment C.

The following treatments will be given during the study:

• Treatment A: single dose of AZD4954 alone.
• Treatment B: single dose of laroprovstat alone.
• Treatment C: single doses of laroprovstat + AZD4954.

The study will comprise of a Screening Period, two Treatment Periods and follow-up visits.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Treatment Sequence AC; Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).	Drug: AZD4954; AZD4954 will be administered orally.; Drug: Laroprovstat; Laroprovstat will be administered orally.; Other Names: AZD0780
Experimental: Cohort 2: Treatment Sequence BC; Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).	Drug: AZD4954; AZD4954 will be administered orally.; Drug: Laroprovstat; Laroprovstat will be administered orally.; Other Names: AZD0780

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954	To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.	Cohort 1: Day 1 to Day 41
Maximum observed drug concentration (Cmax) of AZD4954	To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.	Cohort 1: Day 1 to Day 41
AUCinf of laroprovstat	To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.	Cohort 2: Day 1 to Day 25
Cmax of laroprovstat	To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.	Cohort 2: Day 1 to Day 25

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Apparent total body clearance (CL/F) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Terminal elimination half-life (t½λz) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Time to reach maximum observed concentration (tmax) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Time of last quantifiable concentration (tlast) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Time delay between drug administration and the first observed concentration (tlag) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4954	To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.	Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
AUClast of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
CL/F of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
t½λz of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tmax of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tlast of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tlag of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
Vz/F of laroprovstat	To describe the PK of laroprovstat when administered alone and in combination with AZD4954.	Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	To assess the safety and tolerability of AZD4954 alone and in combination with laroprovstat; and safety and tolerability of laroprovstat alone and in combination with AZD4954 following oral administration of single doses in healthy participants.	Cohort 1: Up to Day 83; Cohort 2: Up to Day 73

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 9, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Hypercholesterolemia; Dyslipidemias; Drug-drug interaction; Lipoprotein (a)
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypercholesterolemia; Dyslipidemias
• Other Study ID Numbers: D7300C00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No