Healthy ParticipantsPhase 1NCT07622433

A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults

A Phase 1 study testing Laroprovstat/ezetimibe FCDP, Laroprovstat STP and Ezetimibe STP in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there… 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?: Laroprovstat/ezetimibe FCDP, Laroprovstat STP and Ezetimibe STP
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 10 Jun 2026to 6 Sep 2026
Phase: Phase 1

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

Healthy male and female participants aged 18 to 55 years at the time of signing consent.
All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.
Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
Have a Body mass index (BMI) between 18 and 30 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.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.
Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.
Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Brooklyn, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults

Read the detailed description

This is a randomized, open-label, 4-period, single-dose, cross-over study.

The study will comprise of a screening period, 4 treatment periods, and 3 washout periods. The following treatments will be given during the study:

Treatment A: laroprovstat/ezetimibe fixed combination drug product (FCDP) test formulation in fasted state
Treatment B: laroprovstat tablet plus ezetimibe reference formulations in fasted state
Treatment C: laroprovstat/ezetimibe FCDP test formulation in fed state
Treatment D: laroprovstat/ezetimibe FCDP test formulation-slow variant in fasted state

Participants will be randomly assigned to either of the 3 treatment sequences: ABCD, BCAD, or CABD.

Conditions: Healthy Participants
Being tested: Laroprovstat/ezetimibe FCDP, Laroprovstat STP, Ezetimibe STP, Laroprovstat/ezetimibe FCDP-slow variant
Keywords: Fixed Combination Drug Products, Bioavailability, Pharmacokinetics, Cross-over study, Hyperlipidemia, Dyslipidemia, Relative bioavailability, Food effect, Oral Formulations
Medical subject headings: Hyperlipidemias, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laroprovstat/ezetimibe FCDPDrug
Laroprovstat/ezetimibe will be administered orally.
Laroprovstat STPDrug
Laroprovstat will be administered orally.
Ezetimibe STPDrug
Ezetimibe will be administered orally.
Laroprovstat/ezetimibe FCDP-slow variantDrug
Laroprovstat/ezetimibe slow variant will be administered orally

Study groups in NCT07622433
Study group	Role	What they receive
Treatment A	Experimental	Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. Receives: Drug: Laroprovstat/ezetimibe FCDP
Treatment B	Experimental	Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. Receives: Drug: Laroprovstat STP; Drug: Ezetimibe STP
Treatment C	Experimental	Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. Receives: Drug: Laroprovstat/ezetimibe FCDP
Treatment D	Experimental	Each participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. Receives: Drug: Laroprovstat/ezetimibe FCDP-slow variant

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)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Maximum observed drug concentration (Cmax)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Secondary outcomes (7)

Plasma Time to reach maximum observed concentration (tmax)
To examine the pharmacokinetic (PK) profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Terminal elimination half-life (t½λz)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent total body clearance (CL/F)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent volume of distribution based on the terminal phase (Vz/F)
To examine the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as FCDPs or STPs.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUCinf
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUClast
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Cmax
To examine the effect on the PK profiles of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe when administered as an FCDP with a high-fat meal compared to when administered as an FCDP in the fasted state.
Measured: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20266 Sep 2026

First posted3 Jun 2026
Study start10 Jun 2026
Primary completion6 Sep 2026
Study completion6 Sep 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: Randomised
Intervention model: Crossover
Model description: Each participant will be randomly assigned to one of the 3 treatment sequences: ABCD, BCAD or CABD.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07622433
Sponsor's protocol ID: D7963C00001
Status last verified: Sep 2026
First submitted: 28 May 2026
Last updated: 28 Sep 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
Endothelial Dysfunction, Inflammation in Cardiopulmonary and Vascular Disease States
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Active, not recruitingPhase 1
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
Healthy Volunteer, Muscular Atrophy, Spinal
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

All Healthy Participants trials