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Study of Laroprovstat and Ezetimibe Combinations in Healthy Adults

This study is looking at how your body handles two medications, laroprovstat and ezetimibe, when they are given together in a single pill compared to when they are given separately. Researchers also want to see if eating affects how your body absorbs the combined medication. This is a small study involving 18 healthy adults between 18 and 55 years old. To join, you must be healthy, and women must not be pregnant or breastfeeding and use effective birth control if sexually active. The study will measure how much of the drugs are in your blood over time (pharmacokinetics) to understand how well the combined pill works compared to the individual pills.

Study design
This is a randomized, open-label (meaning you and the researchers will know which treatment you are receiving), cross-over study with 18 healthy adult participants.
What's involved
You will participate in a screening period, four treatment periods, and three washout periods. Each treatment period lasts 11 days.
Compensation
Not stated in the trial record.
Follow-up
Drug levels will be measured from Day 1 to Day 11 of each of the four treatment periods.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07622433

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

Active, Not Recruiting
PHASE1Ages 18–55InterventionalTreatment
AstraZeneca
~18 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Laroprovstat/ezetimibe FCDPLaroprovstat STPEzetimibe STPLaroprovstat/ezetimibe FCDP-slow variant

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under concentration-time curve from time 0 to infinity (AUCinf)
Measured over Day 1 to 11 of Treatment Periods 1, 2, 3, and 4 (each treatment period is 11 days)
+2 more outcomes measured

Conditions

Healthy Participants

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Healthy Volunteers

NCT07622433

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Brooklyn, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Area under concentration-time curve from time 0 to infinity (AUCinf)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)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)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.