Healthy ParticipantsPhase 1NCT07513571
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults
A Phase 1 study testing AZD4954 and Laroprovstat in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD4954 and Laroprovstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 8 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- AZD4954, Laroprovstat
- Keywords
- Pharmacokinetics, Drug-drug interaction, Dyslipidemias, Hypercholesterolemia, Lipoprotein (a)
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4954Drug
AZD4954 will be administered orally.
LaroprovstatDrug
Also called AZD0780
Laroprovstat will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Treatment Sequence AC | Experimental | Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C). Receives: Drug: AZD4954; Drug: Laroprovstat |
| Cohort 2: Treatment Sequence BC | Experimental | Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C). Receives: Drug: AZD4954; Drug: Laroprovstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cohort 2: Day 1 to Day 25
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cohort 1: Up to Day 83; Cohort 2: Up to Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start10 Apr 2026
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513571
- Sponsor's protocol ID
- D7300C00002
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults.
- ClinicalTrials.gov ID
- NCT07513571
- Acronym / sponsor ID
- D7300C00002
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Drug-drug interaction, Dyslipidemias, Hypercholesterolemia, Lipoprotein (a)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Treatment Sequence AC | Experimental | Drug: AZD4954, Drug: LaroprovstatParticipant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
| Cohort 2: Treatment Sequence BC | Experimental | Drug: AZD4954, Drug: LaroprovstatParticipant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4954AZD4954 will be administered orally. | Drug | Cohort 1: Treatment Sequence AC, Cohort 2: Treatment Sequence BC |
| LaroprovstatAlso: AZD0780Laroprovstat will be administered orally. | Drug | Cohort 1: Treatment Sequence AC, Cohort 2: Treatment Sequence BC |
Primary outcome
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.
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.
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.
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.
15 secondary outcomes
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
Apparent total body clearance (CL/F) of AZD4954
Time frame: Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
Terminal elimination half-life (t½λz) of AZD4954
Time frame: Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
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
Time of last quantifiable concentration (tlast) of AZD4954
Time frame: 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
Time frame: 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
Time frame: Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
AUClast of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
CL/F of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
t½λz of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tmax of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tlast of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
tlag of laroprovstat
Time frame: Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25
Vz/F of laroprovstat
Time frame: 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)
Time frame: Cohort 1: Up to Day 83; Cohort 2: Up to Day 73
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4954 and Laroprovstat in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954 (time frame: Cohort 1: Day 1 to Day 41). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.