Status:
COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers; High Cholesterol
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Partic...
Eligibility Criteria
Inclusion
- Male
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion
- Known or suspected hypersensitivity to study interventions or related products
- Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening
- Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
- History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05333107
Start Date
April 12 2022
End Date
September 23 2022
Last Update
July 12 2024
Active Locations (2)
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1
Altasciences
Cypress, California, United States, 90630
2
Altasciences Clinical Los Angeles, Inc.
Los Angeles, California, United States, 90630