Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules
- Conditions
- dyslipidemiaCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12621000101886
- Lead Sponsor
- yndra Therapeutics, Inc. (Lyndra)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
1. Men and women aged 18 to 64 years of age.
2. Individuals in good current health, in the Investigator’s opinion, as evidenced on review of medical history that includes no significant GI abnormalities, physical examination, concomitant medications, and other safety assessments.
3. Body mass index greater than or equal to 18.5 kg/m2 and lesser than 35 kg/m2.
4. Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
5. Willing to comply with all protocol-specified procedures and availability for the duration of the study.
1. Individuals with known clinically significant esophageal or GI disease, including but not limited to:
a. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or individuals with high risk of stricture, i.e., Crohn's disease.
b. Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
c. Prior varices or small or large bowel obstructions.
d. Prior abdominal or upper GI surgery. (Prior uncomplicated laparoscopic procedures are permitted.)
2. Individuals with PILL-5 questionnaire score of 5 or greater.
3. Medical history or current diagnoses indicating the presence of any of the following conditions:
a. Presence of an uncontrolled, unstable, clinically significant medical condition that could put the subject at risk because of participation in the study, interfere with the subject’s ability to participate in the study or influence the interpretation of safety or PK evaluations.
b. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure within 6 months of Screening.
c. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
4. Use of the following medications/treatments in the 2 weeks before enrollment, including:
a. Proton pump inhibitors (PPIs).
b. H2 blockers.
c. Chronic acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs).
d. Prokinetic agents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method