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.
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
- 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
- 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.
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
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 is any effect of eating compared to fasting (food effect) 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07622433
- Acronym / sponsor ID
- D7963C00001
- Conditions
- Healthy Participants
- Keywords
- Fixed Combination Drug Products, Bioavailability, Pharmacokinetics, Cross-over study, Hyperlipidemia, Dyslipidemia, Relative bioavailability, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 6 Sep 2026 (actual)
- Study completion
- 6 Sep 2026 (actual)
- First posted
- 3 Jun 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 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 is any effect of eating compared to fasting (food effect) in healthy adults.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each participant will be randomly assigned to one of the 3 treatment sequences: ABCD, BCAD or CABD.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Laroprovstat/ezetimibe FCDPEach participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fasted state. |
| Treatment B | Experimental | Drug: Laroprovstat STP, Drug: Ezetimibe STPEach participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state. |
| Treatment C | Experimental | Drug: Laroprovstat/ezetimibe FCDPEach participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation in a fed state. |
| Treatment D | Experimental | Drug: Laroprovstat/ezetimibe FCDP-slow variantEach participant will receive single dose treatment of laroprovstat/ezetimibe FCDP test formulation (slow variant) in a fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 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.
- 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.
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 |
|---|---|---|
| Laroprovstat/ezetimibe FCDPLaroprovstat/ezetimibe will be administered orally. | Drug | Treatment A, Treatment C |
| Laroprovstat STPLaroprovstat will be administered orally. | Drug | Treatment B |
| Ezetimibe STPEzetimibe will be administered orally. | Drug | Treatment B |
| Laroprovstat/ezetimibe FCDP-slow variantLaroprovstat/ezetimibe slow variant will be administered orally | Drug | Treatment D |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
Maximum observed drug concentration (Cmax)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
To evaluate the relative bioavailability between the FCDPs and the STPs of laroprovstat, ezetimibe (unconjugated), ezetimibe-glucuronide, and total ezetimibe.
7 secondary outcomes
Plasma Time to reach maximum observed concentration (tmax)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Terminal elimination half-life (t½λz)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Apparent total body clearance (CL/F)
Time frame: 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)
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUCinf
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
AUClast
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
Cmax
Time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
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 28 Sep 2026.
- THANK YOU CARDLink provided by the sponsor.
- 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 Laroprovstat/ezetimibe FCDP, Laroprovstat STP and Ezetimibe STP 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 4 inclusion and 5 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 28 Sep 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) (time frame: Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)). The study lists 3 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 28 Sep 2026.