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

AstraZeneca

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Laroprovstat; Drug: AZD4954

Study type: Interventional

Funder types: Industry

Identifiers

NCT07513571

D7300C00002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Cohort 1: Treatment Sequence AC

Experimental group

Description:

Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).

Treatment:

Drug: AZD4954

Drug: Laroprovstat

Cohort 2: Treatment Sequence BC

Experimental group

Description:

Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).

Treatment:

Drug: AZD4954

Drug: Laroprovstat