First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: NNC0113-2023
Drug: Placebo (NNC0113-2023)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03617081
NN9023-4408
U1111-1209-3837 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.

Enrollment

40 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 kg/m^2 and 29.9 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

  • HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.
  • Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
  • Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • Presence or history of pancreatitis (acute or chronic).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

NNC0113-2023
Experimental group
Description:
Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.
Treatment:
Drug: NNC0113-2023
Placebo
Placebo Comparator group
Description:
Participants will receive placebo (NNC0113-2023)
Treatment:
Drug: Placebo (NNC0113-2023)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems