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NCT Number: NCT05091073

A Research Study Looking at the Effect of Food Intake on How the Medicine NN0385-0434 Behaves in the Body of Healthy Participants

In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.

NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood.

The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given.

The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.

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Key information

Conditions

Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk Dyslipidemias Elevated Cholesterol Healthy Volunteers Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male.
  • Aged 18 to 55 (both inclusive).
  • Considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.
  • Body weight minimum 54 kg.
  • Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).

Exclusion criteria

  • Any disorder, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
  • Meal habits and diet requirements which are contradictory to the meals provided or unwillingness to eat the food provided in the study.
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Treatment and study plan

NNC0385-0434

Drug

All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days

Primary outcomes

  1. AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from 0 to 24 h after last dose of oral NNC0385-0434

    Time frame: From last dose (Day 10) to 24 hours post treatment (Day 11)

    h*nmol/L

Secondary outcomes

  1. Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434

    Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)

    nmol/L

  2. tmax,0434,Day10: the time to maximum observed plasma concentration of NNC0385-0434 after last dose of NNC0385-0434

    Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)

    hours

  3. t1/2,0434,Day10: the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434

    Time frame: From last dose (Day 10) to post treatment follow-up (Day 65)

    hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Food on the Pharmacokinetics of Oral NNC0385-0434 in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Dec 26, 2023

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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