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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT07316608

Run by

AstraZeneca

People needed

44

Starts

2026-03-16

Expected to finish

2026-06-05

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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).
• 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.

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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