A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults

NCT07316608 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: D7961C00005
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Participants

Keywords

Hyperlipidemia; Dyslipidemia; Relative Bioavailability; Pharmacokinetics; Food effect; Fixed combination drug products; Single therapy products; Oral formulations

Outcome Measures

Primary Outcomes (3)

• 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)

  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).

  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)

  At predefined intervals from Day 1 to Day 11

Secondary Outcomes (13)

• Terminal rate constant (λz)

  At predefined intervals from Day 1 to Day 11

• Time to reach maximum observed concentration (tmax)

  At predefined intervals from Day 1 to Day 11

• Terminal elimination half life (t1/2λz)

  At predefined intervals from Day 1 to Day 11

• Apparent total body clearance (CL/F)

  At predefined intervals from Day 1 to Day 11

• Apparent volume of distribution based on the terminal phase (V/F)

  At predefined intervals from Day 1 to Day 11

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Drug: Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1

Interventions

Laroprovstat Dose X STP DRUG

Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

Cohort 1 Treatment C; Cohort 2 Treatment F

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 DRUG

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.

Cohort 1 Treatment B

Rosuvastatin Dose 1 STP DRUG

Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

Cohort 1 Treatment C

Rosuvastatin Dose 2 STP DRUG

Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.

Cohort 2 Treatment F

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 DRUG

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.

Cohort 2 Treatment E

Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 DRUG

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.

Cohort 1 Treatment A

Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 DRUG

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.

Cohort 2 Treatment D; Cohort 2 Treatment G

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (2)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Brooklyn, Maryland, 21225, United States

Location

Related Links

• TY card

MeSH Terms

Conditions

Hyperlipidemias; Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: March 16, 2026
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (2)