Clinical trial NCT06284798: A Research Study of a New Medicine (NNC0650-0013) in Healthy Men
Official title: A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 75)
Secondary outcomes:
measure: S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow up visit (day 75)
measure: S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose
timeFrame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
measure: S.C. and I.V. Cohort: AUC0-∞,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
timeFrame: From pre-dose (day1) until completion of the follow-up visit (day 75)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency' (dept. 2834)
role: STUDY_DIRECTOR
References: