A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Phase 1
Completed
- Conditions
- Healthy Volunteers; High Cholesterol
- Interventions
- Registration Number
- NCT05333107
- Lead Sponsor
- Novo Nordisk A/S
- 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). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 152
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequence 1 NNC0385-0434 G Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Sequence 1 NNC0385-0434 B Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Sequence 2 NNC0385-0434 G Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Sequence 3 NNC0385-0434 B Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Sequence 4 NNC0385-0434 G Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). Sequence 5 NNC0385-0434 G Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). Sequence 5 NNC0385-0434 B Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). Sequence 6 NNC0385-0434 F Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Sequence 6 NNC0385-0434 B Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Sequence 2 NNC0385-0434 F Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Sequence 3 NNC0385-0434 F Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Sequence 4 NNC0385-0434 F Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
- Primary Outcome Measures
Name Time Method AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval From 0 to 24 hours after dose administration on visit 2, day 10 Measured in h \* nmol/L
- Secondary Outcome Measures
Name Time Method Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434 From 0 to 24 hours after dose administration on visit 2, day 10 Measured in nmol/L
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434 From 0 to 24 hours after dose administration on visit 2, day 10 Measured in hours
Trial Locations
- Locations (2)
Altasciences Clinical Los Angeles, Inc.
🇺🇸Los Angeles, California, United States
Altasciences
🇺🇸Cypress, California, United States