A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults

AstraZeneca31 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

AZD4954DRUG

AZD4954 will be administered orally.

LaroprovstatDRUG

Laroprovstat will be administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Glendale, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Cohort 2: Day 1 to Day 25

Secondary Outcomes

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.

Time frame: 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.

Time frame: Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

Terminal elimination half-life (t½λz) of AZD4954

Data from ClinicalTrials.gov

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