Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT07011992
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07011992
Study Brief:
Protocol Section:
NCT07011992