A Research Study of a New Medicine (NNC0650-0013) in Healthy Men

Healthy Participants Clinical Trial

Official title:

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284798
• Other study ID #: NN9650-5027
• Secondary ID: 2023-506134-79U1
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2024
• Est. completion date: March 22, 2025

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 22, 2025
• Est. primary completion date: March 22, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male.

• Age 18-55 years (both inclusive) at the time of signing the informed consent.

• Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.

• Considered to be otherwise 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, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.

• Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• NNC0650-0013 A
NNC0650-0013 will be administered subcutaneously or intravenously.
• Placebo
Subcutaneous administration.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S.C. Cohort: Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From time of dosing (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. Cohort: AUC0-8,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose	Measured as hours nanomoles per liter (h*nmol/L).	From pre-dose (day 1) until completion of the follow up visit (day 75)
Secondary	S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. Cohort: AUC0-8,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. Cohort: AUC0-8,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	I.V. Cohort: AUC0-8,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	I.V. Cohort: AUC0-8,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	I.V. Cohort: AUC0-8,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
Secondary	S.C. and I.V. Cohort: AUC0-8,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered	Measured as hours nanomoles per milligram (h*nmol/mg).	From pre-dose (day1) until completion of the follow-up visit (day 75)