Could a single pill replace two? new combo drug tested in healthy volunteers
NCT ID NCT07316608
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study tested whether a single tablet combining laroprovstat and rosuvastatin works as well as taking the two drugs separately. 44 healthy adults aged 18 to 55 took part in a crossover design, receiving different formulations. The goal was to measure how much of each drug gets into the blood, not to treat any condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laroprovstat and rosuvastatin combined in a single tablet
- What this could lead to
- If successful, this could lead to a simpler, single-pill option for people who need both laroprovstat and rosuvastatin, making it easier to take their medications.
- What could go wrong
- This is an early-stage trial in healthy volunteers, not patients. It only measures how the body processes the drugs, not whether they work for any disease. The combined tablet may not work as well as separate pills.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
44 people
The number who actually took part.
- Started
-
Mar 2026
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy participants are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Glendale, California, 91206, United States
-
Research Site
Brooklyn, Maryland, 21225, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Does it matter where you inject? scientists test Weight-Loss drug in arm, thigh, and belly
- New drug RO7830698 put to the test for COPD
- Three pill versions of one drug go head to head in the bloodstream
- Pfizer tests RSV vaccine aimed at older adults
- Radioactive tracer maps where a new drug goes in the body
- Radioactive tag lets scientists follow an experimental drug through the human body