Healthy ParticipantsPhase 1NCT07316608
A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults
A Phase 1 study testing Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1, Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 and Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults. 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 Dose X/Rosuvastatin Dose 1 FCDP test formulation 1, Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 and Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Mar 2026to 5 Jun 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
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, in addition to a barrier method, to avoid pregnancy from the time of first administration of study intervention until 10 days after discharge from the study site.
- Females of non-childbearing potential must be confirmed at the Screening Visit by checking if they are postmenopausal [amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range] or by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 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 prior gastrointestinal surgery which may affect absorption, example (eg), gastric bypass or resection.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Asian origin.
- Any laboratory values with the following deviations at the Screening Visit or on admission to the study site. Abnormal values may be repeated once at the discretion of the investigator:
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- ALT > upper limit of normal (ULN).
- AST > ULN.
- TBL > ULN.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.
- Hemoglobin < lower limit normal (LLN).
- Creatine kinase > 5 × ULN.
- Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results other than those listed above, at screening and/or admission to the study site, as judged by the investigator. Abnormal values may be repeated once at the discretion of the investigator.
- 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).
- Abnormal vital signs, after 10 minutes supine rest, at the Screening Visit and/or admission to the study site, defined as any of the following. Abnormal values may be repeated once (one triplicate measurement) at the discretion of the investigator:
- Systolic Blood pressure (BP) < 90 mmHg or ≥ 140 mmHg.
- Diastolic BP < 50 mmHg or ≥ 90 mmHg.
- Pulse rate < 45 or > 90 beats per minute (bpm).
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening and/or admission to the study site, as judged by the investigator. Abnormal values may be repeated once at the discretion of the investigator.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months prior to screening.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator in the last one year.
- Positive screen for drugs of abuse, alcohol, or cotinine at screening or on each admission to the study site.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to laroprovastat or rosuvastatin.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (eg, > 5 cups of coffee [one cup ~100 mg caffeine]; one cup of tea ~30 mg caffeine) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the study site.
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, intake of > 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life. Hormonal contraceptives (for females of childbearing potential) are allowed.
- Treatment with any lipid lowering therapy or laroprovastat 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 (approved or investigational and apart from laroprovstat).
- Current or previous administration of inclisiran.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- Has received any Investigational Medicinal Product (IMP-defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of study intervention in this study.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Participants who have medical dietary restrictions or are unable/unwilling to comply with the meals provided in the unit during the stay at the study site.
- Participants who cannot communicate reliably with the investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I, Randomized, Open-label, 3 or 4-period, 7-treatment, Single-dose, Two Cohort, Crossover Study to Assess the Relative Bioavailability of Laroprovstat/Rosuvastatin Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.
Read the detailed description
This is a randomized, open-label, 3 or 4-period, single-dose, two-cohort, multi-center, crossover study. The study will comprise of a screening period (21 Days), 3 or 4 treatment periods (depending on cohort assignment) and washout period (14 Days, starting after dosing on Study Day 1 of a given treatment period). Each treatment period consists of dosing on Day 1; any subsequent treatment period will not start sooner than 14 days following dosing in the previous treatment period.
- Conditions
- Healthy Participants
- Being tested
- Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1, Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1, Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2, Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2, Laroprovstat Dose X STP
- Keywords
- Hyperlipidemia, Dyslipidemia, Relative Bioavailability, Pharmacokinetics, Food effect, Fixed combination drug products, Single therapy products, 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 Dose X/Rosuvastatin Dose 1 FCDP test formulation 1Drug
Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1Drug
Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2Drug
Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2Drug
Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X STPDrug
Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Rosuvastatin Dose 1 STPDrug
Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Rosuvastatin Dose 2 STPDrug
Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Treatment A | Experimental | Participants will receive a single oral Fixed Combination Drug Product (FCDP) test formulation 1 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. Receives: Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 |
| Cohort 1 Treatment B | Experimental | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. Receives: Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 |
| Cohort 1 Treatment C | Experimental | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 1 rosuvastatin as Single Therapy Product (STP) reference formulations following an overnight fast. Receives: Drug: Laroprovstat Dose X STP; Drug: Rosuvastatin Dose 1 STP |
| Cohort 2 Treatment D | Experimental | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. Receives: Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 |
| Cohort 2 Treatment E | Experimental | Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. Receives: Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 |
| Cohort 2 Treatment F | Experimental | Participants will receive a single oral Dose X laroprovstat and a single oral Dose 2 rosuvastatin as STP reference formulations following an overnight fast. Receives: Drug: Laroprovstat Dose X STP; Drug: Rosuvastatin Dose 2 STP |
| Cohort 2 Treatment G | Experimental | Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin in a fed state. Receives: Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 |
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 FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
Measured: At predefined intervals from Day 1 to Day 11
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2).
Measured: At predefined intervals from Day 1 to Day 11
Maximum observed drug concentration (Cmax)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
Measured: At predefined intervals from Day 1 to Day 11
Secondary outcomes (13)
Terminal rate constant (λz)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Measured: At predefined intervals from Day 1 to Day 11
Time to reach maximum observed concentration (tmax)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Measured: At predefined intervals from Day 1 to Day 11
Terminal elimination half life (t1/2λz)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Measured: At predefined intervals from Day 1 to Day 11
Apparent total body clearance (CL/F)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Measured: At predefined intervals from Day 1 to Day 11
Apparent volume of distribution based on the terminal phase (V/F)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Measured: At predefined intervals from Day 1 to Day 11
AUCinf
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals from Day 1 to Day 11
AUClast
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals from Day 1 to Day 11.
Cmax
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals form Day 1 to Day 11
tmax
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals from Day 1 to Day 11
λz
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals form Day 1 to Day 11
t1/2λz
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals from Day 1 to Day 11.
CL/F
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals form Day 1 to Day 11
V/F
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Measured: At predefined intervals from Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start16 Mar 2026
- Primary completion5 Jun 2026
- Study completion5 Jun 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316608
- Sponsor's protocol ID
- D7961C00005
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2025
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-label, 3 or 4-period, 7-treatment, Single-dose, Two Cohort, Crossover Study to Assess the Relative Bioavailability of Laroprovstat/Rosuvastatin Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
- ClinicalTrials.gov ID
- NCT07316608
- Acronym / sponsor ID
- D7961C00005
- Conditions
- Healthy Participants
- Keywords
- Hyperlipidemia, Dyslipidemia, Relative Bioavailability, Pharmacokinetics, Food effect, Fixed combination drug products, Single therapy products, Oral formulations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 5 Jan 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 rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.
Detailed description
This is a randomized, open-label, 3 or 4-period, single-dose, two-cohort, multi-center, crossover study. The study will comprise of a screening period (21 Days), 3 or 4 treatment periods (depending on cohort assignment) and washout period (14 Days, starting after dosing on Study Day 1 of a given treatment period). Each treatment period consists of dosing on Day 1; any subsequent treatment period will not start sooner than 14 days following dosing in the previous treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Treatment A | Experimental | Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1Participants will receive a single oral Fixed Combination Drug Product (FCDP) test formulation 1 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment B | Experimental | Drug: Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast. |
| Cohort 1 Treatment C | Experimental | Drug: Laroprovstat Dose X STP, Drug: Rosuvastatin Dose 1 STPParticipants will receive a single oral Dose X laroprovstat and a single oral Dose 1 rosuvastatin as Single Therapy Product (STP) reference formulations following an overnight fast. |
| Cohort 2 Treatment D | Experimental | Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment E | Experimental | Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast. |
| Cohort 2 Treatment F | Experimental | Drug: Laroprovstat Dose X STP, Drug: Rosuvastatin Dose 2 STPParticipants will receive a single oral Dose X laroprovstat and a single oral Dose 2 rosuvastatin as STP reference formulations following an overnight fast. |
| Cohort 2 Treatment G | Experimental | Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin in a fed state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, in addition to a barrier method, to avoid pregnancy from the time of first administration of study intervention until 10 days after discharge from the study site.
- Females of non-childbearing potential must be confirmed at the Screening Visit by checking if they are postmenopausal [amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range] or by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
Key exclusion criteria (37 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 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 prior gastrointestinal surgery which may affect absorption, example (eg), gastric bypass or resection.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Asian origin.
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 Dose X/Rosuvastatin Dose 1 FCDP test formulation 1Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 1 Treatment A |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 2 Treatment D, Cohort 2 Treatment G |
| Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 1 Treatment B |
| Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 2 Treatment E |
| Laroprovstat Dose X STPLaroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 1 Treatment C, Cohort 2 Treatment F |
| Rosuvastatin Dose 1 STPRosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 1 Treatment C |
| Rosuvastatin Dose 2 STPRosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period. | Drug | Cohort 2 Treatment F |
Primary outcome
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: At predefined intervals from Day 1 to Day 11
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: At predefined intervals from Day 1 to Day 11
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2).
Maximum observed drug concentration (Cmax)
Time frame: At predefined intervals from Day 1 to Day 11
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
13 secondary outcomes
Terminal rate constant (λz)
Time frame: At predefined intervals from Day 1 to Day 11
Time to reach maximum observed concentration (tmax)
Time frame: At predefined intervals from Day 1 to Day 11
Terminal elimination half life (t1/2λz)
Time frame: At predefined intervals from Day 1 to Day 11
Apparent total body clearance (CL/F)
Time frame: At predefined intervals from Day 1 to Day 11
Apparent volume of distribution based on the terminal phase (V/F)
Time frame: At predefined intervals from Day 1 to Day 11
AUCinf
Time frame: At predefined intervals from Day 1 to Day 11
AUClast
Time frame: At predefined intervals from Day 1 to Day 11.
Cmax
Time frame: At predefined intervals form Day 1 to Day 11
tmax
Time frame: At predefined intervals from Day 1 to Day 11
λz
Time frame: At predefined intervals form Day 1 to Day 11
t1/2λz
Time frame: At predefined intervals from Day 1 to Day 11.
CL/F
Time frame: At predefined intervals form Day 1 to Day 11
V/F
Time frame: At predefined intervals from Day 1 to Day 11
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 17 Jun 2026.
- TY 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.
2 sites 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 Dose X/Rosuvastatin Dose 1 FCDP test formulation 1, Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 and Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 in people with Healthy Participants, run by AstraZeneca at 2 sites 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 6 inclusion and 37 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: At predefined intervals from Day 1 to Day 11). 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 17 Jun 2026.