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NCT Number: NCT07513571

A 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Glendale, California, 91206, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD4954

Drug

AZD4954 will be administered orally.

Laroprovstat

Drug

Laroprovstat will be administered orally.

Other names: AZD0780

Primary outcomes

  1. Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954

    Time frame: Cohort 1: Day 1 to Day 41

    To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.

  2. Maximum observed drug concentration (Cmax) of AZD4954

    Time frame: Cohort 1: Day 1 to Day 41

    To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.

  3. AUCinf of laroprovstat

    Time frame: Cohort 2: Day 1 to Day 25

    To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.

  4. Cmax of laroprovstat

    Time frame: Cohort 2: Day 1 to Day 25

    To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.

Secondary outcomes

  1. Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  2. Apparent total body clearance (CL/F) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  3. Terminal elimination half-life (t½λz) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  4. Time to reach maximum observed concentration (tmax) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  5. Time of last quantifiable concentration (tlast) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  6. Time delay between drug administration and the first observed concentration (tlag) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  7. Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4954

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

    To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

  8. AUClast of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  9. CL/F of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  10. t½λz of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  11. tmax of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  12. tlast of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  13. tlag of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  14. Vz/F of laroprovstat

    Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25

    To describe the PK of laroprovstat when administered alone and in combination with AZD4954.

  15. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Cohort 1: Up to Day 83; Cohort 2: Up to Day 73

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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