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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Elevated Cholesterol; Healthy Volunteers; Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk

Treatments: Drug: NNC0385-0434

Study type: Interventional

Funder types: Industry

Identifiers

NCT05091073

U1111-1264-4693 (Other Identifier)

2021-000430-34 (EudraCT Number)

NN6435-4826

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

Fed group

Experimental group

Description:

Fed dosing conditions

Treatment:

Drug: NNC0385-0434

Fasting group

Experimental group

Description:

Fasting dosing conditions

Treatment:

Drug: NNC0385-0434

Reference group

Active Comparator group

Description:

Reference dosing conditions

Treatment:

Drug: NNC0385-0434