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Completed

NCT Number: NCT05333107

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC0385-0434 G

Drug

Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

NNC0385-0434 F

Drug

Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

NNC0385-0434 B

Drug

Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

Primary outcomes

  1. AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval

    Time frame: From 0 to 24 hours after dose administration on visit 2, day 10

    Measured in h * nmol/L

Secondary outcomes

  1. Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434

    Time frame: From 0 to 24 hours after dose administration on visit 2, day 10

    Measured in nmol/L

  2. tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434

    Time frame: From 0 to 24 hours after dose administration on visit 2, day 10

    Measured in hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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