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

Effect of Food on the Pharmacokinetics of Oral NNC0385-0434 in 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Elevated Cholesterol; Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk
• Intervention / Treatment: Drug: NNC0385-0434

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed group; Fed dosing conditions	Drug: NNC0385-0434; All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
Experimental: Fasting group; Fasting dosing conditions	Drug: NNC0385-0434; All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days
Active Comparator: Reference group; Reference dosing conditions	Drug: NNC0385-0434; All participants will be dosed with 40 mg oral NNC0385-0434 once-daily for 10 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	h*nmol/L	From last dose (Day 10) to 24 hours post treatment (Day 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434	nmol/L	From last dose (Day 10) to post treatment follow-up (Day 65)
tmax,0434,Day10: the time to maximum observed plasma concentration of NNC0385-0434 after last dose of NNC0385-0434	hours	From last dose (Day 10) to post treatment follow-up (Day 65)
t1/2,0434,Day10: the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434	hours	From last dose (Day 10) to post treatment follow-up (Day 65)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis
• Other Study ID Numbers: NN6435-4826; U1111-1264-4693 (Other Identifier: World Health Organization (WHO)); 2021-000430-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No