An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules in Healthy Volunteers

yndra Therapeutics, Inc. (Lyndra)0 sites16 target enrollmentFebruary 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 1, 2021

End Date

March 19, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

yndra Therapeutics, Inc. (Lyndra)

•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.