A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

Healthy Volunteers Type 2 Diabetes Clinical Trial

Official title:

Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878406
• Other study ID #: NN9389-4680
• Secondary ID: U1111-1263-7182
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: May 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male aged 20-55 years (both inclusive) at the time of signing the informed consent.

• Both parents of Japanese descent.

• Body mass index between 20.0 kg/m^2 and 24.9 kg/m^2 (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:

• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

• Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Related Conditions & MeSH terms

• Healthy Volunteers Type 2 Diabetes

Intervention

Drug:
• NNC0480-0389
A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.
• Placebo (NNC0480-0389)
A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.
• Semaglutide
A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.
• Placebo (Semaglutide)
A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Count of events	From time of dosing (day 1) until completion of the follow-up visit (day 43)
Secondary	AUC0-8,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose	Measured in nmol*h/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary	Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose	Measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary	AUC0-8,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose	Measured in nmol*h/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary	Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose	Measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)