None listed
Conditions
Brief summary
This is a single center, open-label, study of rosuvastatin 140 mg ER capsules (LYN-047) to evaluate its safety, tolerability, and PK when administered as 2 weekly doses in healthy male and female volunteers.
Interventions
This study involves Screening from Day -28 to Day -8; Immediate release rosuvastatin dosing on Day -6, followed by a 5-day washout; and LYN-047 dosing and follow-up from Day 1 through Day 21. Therefore, patient participation in the study will range from 29 to 49 days (7 weeks).
Dosage form: Capsule containing a drug releasing formulation.
Route of administration: Oral
All participants will receive 2 doses of LYN-047(140mg), the first on Day 1 and the second on Day 8.
Immediate release rosuvast
This study involves Screening from Day -28 to Day -8; Immediate release rosuvastatin dosing on Day -6, followed by a 5-day washout; and LYN-047 dosing and follow-up from Day 1 through Day 21. Therefore, patient participation in the study will range from 29 to 49 days (7 weeks). Dosage form: Capsule containing a drug releasing formulation. Route of administration: Oral All participants will receive 2 doses of LYN-047(140mg), the first on Day 1 and the second on Day 8. Immediate release rosuvastatin of 20 mg tablets will be orally administered. All participants will receive 1 dose of IR rosuvastatin on Day -6. Only clinic staff administer the intervention. Therefore, monitoring adherence is not required.
Sponsors
Lyndra Therapeutics, Inc. (Lyndra)
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed