A Study to Assess the Effects of BPN14770 on Rosuvastatin

Launched by SHIONOGI · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study the effects of a medication called BPN14770 on how the body processes another drug called rosuvastatin, which is often used to manage cholesterol levels. The trial will involve healthy adults, and researchers want to see if BPN14770 affects how rosuvastatin works in the body. The study is currently not recruiting participants, but it will focus on individuals aged between 18 to 88 years old, regardless of gender.

To be eligible for this study, participants must be in good health as confirmed by a medical evaluation, including a physical exam and laboratory tests. They should have a body mass index (BMI) between 18.5 and 32.0. It's also important for women to have a negative pregnancy test before participating. However, individuals with certain medical conditions, a history of severe allergies, or those who have previously experienced side effects from rosuvastatin are not eligible to join. Participants in the trial can expect to undergo thorough medical assessments and will be monitored closely throughout the study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety
• • Body mass index ≥18.5 and \<32.0 kilograms/meter squared
• • All female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)
• Key Exclusion Criteria:
• • Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intraocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment
• • Known history of allergic reaction to multiple medications and/or severe allergic reaction to any food or environmental allergens
• • Prior use of rosuvastatin that was discontinued for tolerability or adverse events
• • Received ≥4 types of investigational study interventions within 12 months prior to administration of study intervention
• • Positive drug or alcohol screen test result at screening or upon admission
• • Use of cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission
• • Note: Other protocol-defined inclusion/exclusion criteria may apply