Clinical trial NCT05333107: A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Official title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers; High Cholesterol
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 152
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
timeFrame: From 0 to 24 hours after dose administration on visit 2, day 10
Secondary outcomes:
measure: Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
timeFrame: From 0 to 24 hours after dose administration on visit 2, day 10
measure: tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434
timeFrame: From 0 to 24 hours after dose administration on visit 2, day 10
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences
state: California
city: Los Angeles
country: United States
facility: Altasciences Clinical Los Angeles, Inc.
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: